Abbott Laboratories Recalls
Showing 1-20 of 87 recalls
ARCHITECT STAT Troponin-I Reagent Kit, REF 2K41-27
One lot of reagent was manufactured with insufficient quantities of the heterophilic blocking agents in the conjugate component.
On July 26, 2022, Abbott issued a Product Recall letter for this issue sent the letter via FedEx priority overnight express. The letter provided the reason for the recall and hazard involved and requested the consignee take the following actions: "" IMMEDIATELY discontinue use of ARCHITECT STAT Troponin-I, List Number 2K41-27 lot number 63718UN22 and destroy all inventory of lot 63718UN22 according to your laboratory procedures. " Please contact Customer Support to order replacement material. " Please review this letter with your Medical Director or Laboratory Management and follow your laboratory protocol regarding the need for review of previously reported patient results using lot number 63718UN22. " Complete and return the Customer Reply Form. " If you have forwarded the product listed above to other laboratories, please inform them of this Product Recall and provide to them a copy of this letter. " Please retain this letter for your laboratory records." Questions regarding the information were provided the following contact information: If you or any of the health care providers you serve have questions regarding this information, please contact Customer Service at 1-877-4ABBOTT (available 24 hours a day, 7 days a week).
REF: 4P52-20 Hemoglobin A1c for use with Architect, IVD, CE, R1 1 x 52 mL, R2 1 x 20 mL, A1cDL 2 x 35 mL
There is a potential for falsely elevated Hemoglobin %A1c and Hemoglobin A1c results to be generated using the ARCHITECT and Alinity c Hemoglobin A1c assay.
On June 9, 2022, Abbott issued a "Urgent Medical Device Correction" to affected consignees via FedEx. 1. Immediately install the updated assay file versions listed below (as applicable for your laboratory), and manually configure the Low-Linearity value. The assay files can be obtained from www.corelaboratory.abbott 2. For the whole blood application, manually configure the THbWB Low-Linearity to 53.8278. For the hemolysate application, manually configure the THbH Low-Linearity to 1250. For detailed information on editing assay parameters, refer to Changing assay configuration settings, Change a linearity range in the ARCHITECT System Operations Manual, Section 2. 3. Please review this letter with your Medical Director or Laboratory Management and follow your laboratory protocol regarding the need for reviewing previously reported patient results. 4. Complete and return the Customer Reply Form. 5. Please retain this letter for your laboratory records. 6. If you have forwarded the product listed above to other laboratories, please inform them of this Product Correction and provide to them a copy of this letter.
ARCHITECT STAT Myoglobin Calibrators, RES 2K43-01 The ARCHITECT STAT Myoglobin Calibrators are for the calibration of the ARCHITECT iSystem with STAT protocol capability when used for the quantitative determination of myoglobin in human serum and plasma.
This calibrator lot did not meet acceptance criteria during ongoing stability testing. When a calibration is performed with this lot, controls may exceed the specified range in the Instructions for Use (IFU).
The firm, Abbott, notified their consignees by "Urgent Medical Device Products Recall" letter on 03/08/2022. The letter explained the issue and requested the use of the affected item be discontinued and destroyed, and the Customer Reply Form be completed and returned via FAX #: 1-800-777-0051 or email PMS@abbott.com. The firm is replacing the product. If you or any of the health care providers you serve have questions regarding this information, U.S. Customers please contact Customer Service at 1-877-4ABBOTT (available 24 hours a day, 7 days a week).
ARCHITECT i1000SR REF 01L86-01/1L86 and 1L87; ARCHITECT i2000SR REF 03M74-02/3M74; ARCHITECT i2000 REF 08C89-01/1G17 and 8C89
Twelve software-related issues affecting software version 9.41 and earlier were identified. The issues include bypassing error codes, incorrect calibration, loss of module communication leading to overfilling wash buffer containers, missing QC flags, signal spikes, abnormal optics reads, and incorrect sample aspiration. The issues may lead to inaccurate results with an unknown bias direction and magnitude for assays measuring cardiac, metabolic (including diabetes), toxicology, prenatal, therapeutic drug monitoring, infectious disease, oncology, hepatic, pancreatic, hematological, endocrinologic, inflammatory analytes.
On 09/29/2021, the Firm issued an "Urgent Medical Device Correction" Notification Letter via FedEx priority overnight express informing customers that the Firm has identified 3 potential performance issues with Software version 9.41 and earlier. The 3 issues are: 1. When an Error Code 3382, Unable to process test, internal wash pressure (x) error (y) pipettor occurs, the systems are incorrectly placed into a Scheduled Pause status rather than a Stopped status. As a result, the processing module continues to process tests after the hardware error is detected. This may cause incorrect results to be generated. 2. When configuring a Calibrator Sample Volume on the Configure Assays screen, if the user selects multiple assays, the calibrator sample volume from one assay may be carried into the calibrator sample volume for another assay. Incorrect calibrator sample volumes have the potential to generate incorrect calibration curves which may lead to incorrect results and delay of results due to the need to reconfigure assay parameters. 3. When performing a backup on the system while the iARM is replenishing the wash buffer at the same time, the iARM looses communication with the System Control Center. The loss of communication may cause the wash buffer container to overflow. This has the potential to lead to physical and chemical hazards. Customers are instructed to follow the Necessary Actions listed in Appendix A until software version 9.45 or software version 9.50 are installed. Appendix A states: For Issue (listed above): #1-The Necessary Actions to be taken by the customers until mandatory upgrade is completed - Stop the processing module and discard any results produced after an Error Code 3382. Perform Corrective Actions for Error Code 3382. For details, refer to System Operations Manual, Section 10: Troubleshooting and diagnostics. #2-The Necessary Actions to be taken by the customers until mandatory upgrade is completed - Verify the correct calibrator sample v
Alinity ci-series System Control Module clinical chemistry and immunoassay analyzer for in vitro diagnostic use. Model number LN 03R70-01
Due to potential performance issues with software version 3.2.3 and earlier. Performance issues are: 1) There is the potential for onboard reagents past their lot expiration date or onboard stability time to be incorrectly displayed on the Reagent Status screen with a status of "OK". In this scenario, the expired reagent will remain in the carousel for sample processing. 2) Performing monthly maintenance procedure 5701 Clean ICT Drain Tip incorrectly may potentially cause issues such as damaged connector or leaking connection. 3) A sample exception with message code 150 "Unable to process test. Previous processing module error" is produced without notifying the operator of a reagent pipettor failure and may cause processing module to transition into the Pausing state. Tests initiated prior to the sample exception may continue to process without dispense of reagents, potentially leading to incorrect results. 4. Reagent short dispense: Alinity c needs a control measure to protect against the potential for short reagent dispense. Addition of a maximum depth limit for reagent cartridges on the Alinity c to prevent the potential for a short dispense is needed. 5. RSM indicators were blinking green incorrectly: The Reagent and Sample Manager (RSM) indicators will incorrectly blink green indicating that processing is completed and the rack or cartridge can be removed from the loading area when the rack or cartridge should not be accessed. 6. Erroneous ICT Calibration Curves: Erroneous ICT calibration curves might be generated for the Alinity c when there is a malfunction of ICT reference solution delivery, use of wrong/evaporated calibrator, defective ICT modules, etc.
On 07/26/2021, the firm sent an "Product Correction Urgent-Immediate Action Required" Notification Letter via FedEx priority overnight express informing customers that the Recalling Firm identified three potential performance issues with software version 3.2.3 and earlier and that the Recalling Firm is releasing software version 3.3.0 to correct the following issues: 1. There is the potential for onboard reagents past their lot expiration date or onboard stability time to be incorrectly displayed on the Reagent Status screen with a status of OK . In this scenario, the expired reagent will remain in the carousel for sample processing. 2. Performing monthly maintenance procedure 5701 Clean ICT Drain Tip incorrectly may potentially cause issues such as damaged connector or leaking connection. 3. A sample exception with message code 150 Unable to process test. Previous processing module error is produced without notifying the operator of a reagent pipettor failure. The processing module transitions into the Pausing state. Tests initiated prior to the sample exception may continue to process without dispense of reagents, potentially leading to incorrect results. Customer are instructed to: 1) Follow the Necessary Actions required in Appendix A until software version 3.3.0 is installed. Appendix A is include with the Notification Letter. 2) A Recalling Firm representative will schedule a mandatory upgrade to software version 3.3.0. 3) If customers have forwarded the affected product to other laboratories, inform them of this Product Correction and provide to them a copy of the Notification Letter. 4) Complete the included Customer Reply Form 5) Retain the Notification Letter with their laboratory records. For questions, U.S. Customers can contact Customer Service at 1-877-4ABBOTT (available 24 hours a day, 7 days a week). For Customers outside of the U.S., contact their local area Customer Service.
CELL-DYN Emerald analyzer, REF 09H39-01. The CELL-DYN Emerald is an automated hematology analyzer intended for in-vitro diagnostic use in the clinical laboratory.
There is a potential for the device to generate Quality Control (QC) low or out-of-range low for parameters RBC and PLT.
The recalling firm, Abbott, issued "Product Correction Urgent Immediate Action Required" letters dated 2/21/2019 via FedEx priority overnight express mail on 2/21/2019 to its customers. The letter described the issue, patient impact, and necessary actions. The customers were instructed to follow the necessary actions and complete and return the Customer Reply form via fax, prior to March 7, 2019 via FAX #: 18007770051 or email QAGCO@abbott.com. Even if you no longer have the instrument(s). If you or any of the health care providers you serve have any questions regarding this information, U.S. Customers please contact Customer Service at 18774ABBOTT (available 24 hours a day, 7 days a week). Customers outside the U.S., please contact your local area Customer Service.
REF: 08P1820, Abbott Alinity c Activated Alanine Aminotransferase reagent Kit, Alinity c Activated Alanine Aminotransferase Reagent Kit,, IVD, CE, UDI: (01) 00380740132569
There is a potential for 15% under-recovery on Activated Alanine Aminotransferase (A-ALT) samples greater than 1,200 U/L. In addition there is a potential for a >10% shift in patient results with samples containing bilirubin concentrations greater that 31 mg/dL. This could lead to incorrect patient results.
On June 10, 2021, Abbott issued a Product Correction letter to US consignees via FedEx. In addition to informing consignees about the recall, Abbott asked customers to take the following actions: 1. Immediately install AALT assay file, version 10, obtained from www.corelaboratory.abbott 2. Manually configure the HighLinearity assay parameter to 1,200 U/L. For detailed information, refer to Changing assay configuration settings, Change a linearity range in the ARCHITECT System Operations Manual, Section 2. 3 Complete and return the Customer Reply Form. 4. If you have forwarded the products listed above to other laboratories, please inform them of this Product Correction and provide to them a copy of this letter. 5. Please retain this letter for your laboratory records. 6.If you or any of the health care providers you serve have questions regarding this information, U.S. Customers please contact Customer Service at 18774ABBOTT (available 24 hours a day, 7 days a week). Customers outside the U.S., please contact your local area Customer Service. 7. Adverse reactions or quality problems experienced with the use of this product may be reported to the FDAs MedWatch Adverse Event Reporting program either online (http://www.fda.gov/MedWatch/report.htm), by mail (http://www.fda.gov/MedWatch/getforms.htm), by phone (18003321088), or by fax (1800 FDA0178).
Accelerator APS Aliquoter Module, List number: 07L40 - Product Usage: The ACCELERATOR APS Workcell is a modular system designed to automate sample handling and processing in the clinical laboratory. The system allows consolidations of multiple clinical chemistry and immunoassay analytical instruments into a unified workstation.
In the case of an AQM clot detection error a portion of the distilled water from the Aliquoter Module hydraulic circuit may be dispensed into the Primary Tube leading to sample dilution, which could lead to incorrect results.
On 04/02/2020, Product Correction notices were mailed to customers via overnight service. Customers were asked to do the following to avoid the risk of contamination, take the following precaution: - Discard the Primary Tube flagged with Clot Detection error or manage it according to your laboratory guidelines considering that it may be diluted. - Call Customer Support in case the frequency of the Clot Detection Error increases (more than 5 consecutive Clot Detection Errors). - Please complete the included Abbott Customer Reply Form. - If you have forwarded the product listed above to other laboratories, please inform them of this Product Correction and provide to them a copy of this letter. - Retain this letter for your laboratory records. This information will be added to the Operations Manual, which is expected in Q2 2020. If you or any of the health care providers you serve have any questions regarding this information, please contact Customer Service at 1-877-4ABBOTT (available 24 hours a day, 7 days a week).
ARCHITECT BNP Calibrators Ptoduct Usage: The ARCHITECT BNP Calibrators are for the calibration of the ARCHITECT iSystem when used for the quantitative determination of human Btype natriuretic peptide (BNP) in human EDTA plasma.
Presence of a time dependent, stability drift in patient and control results returned from ARCHITECT BNP testing.
Abbott Laboratories notified customers on about 05/24/2019 via "Product Recall" letter. If customers did not have an alternate calibrator and/or control lots available in inventory and a valid calibration calibration curve has been generated, then customers should immediately order replacement calibrator and/or control lots. Valid calibration curves generated with the affected calibrator lots can still be used as long as controls not listed on the customer notification letter remain within range. The control lots listed in the letter CANNOT be used to validate the calibration curves. Destroy any inventory of the affected lots according to your laboratory procedures. If customers have alternate calibrator and/or control lots available in inventory, then discontinue use of the impacted lots immediately and switch to the alternate calibrator and/or control lots. Destroy any remaining inventory of the calibrator and/or control lots according to your laboratory practices. For customers who have, and are currently using, specified lots (outlined in the customer letter), expiration dates should be adjusted as instructed. Reference customer letter. The ARCHITECT software will continue to track to original dating as assigned during the manufacture of these lots. Manual tracking of the newly assigned expiration dates will have to be performed for each individual instrument, kit, and laboratory. Obtain replacement calibrator and/or controls prior to adjusted expiration to maintain testing. All future calibrator and control lots will have shortened expiration dating and will require adjustments to laboratory inventory and order management practices. Please contact your local Abbott representative for assistance and advice on optimization of workflow in your laboratory. Customers were also instructed to complete and return the Customer Reply form, notify customers if the affected products were further distributed, and retain a copy of the letter for lab
"HEMOGLOBIN A1c CALIBRATORS *** REF 4P52-01 *** 307261/R03 *** S4P5X0 *** FOR USE WITH ARCHITECT" - Product Usage: use in the calibration of the Hemoglobin A1c assay.
Calibrator level 2 bottle may have been manufactured incorrectly for a portion of the lot. The manufacturer observed no impact to assay performance between the HbA1c concentration range of 5.33% to 6.87%. However, outside of this range, a bias of greater than 3% may be seen with patient results. The device failure that is associated with this recall can result in potentially negatively and positively biased patient test results for HbA1c. The firm is investigating the root cause.
On May 22, 2019 the firm issued the Product Recall letter along with a customer reply form to all customers informing them that the firm has identified that the calibrator level 2 may have been manufactured incorrectly for a portion of the lots and that although this lot may generate an active calibration curve, a shift to QC and patient results may occur. Between concentration range of 5.33% to 6.87% there is no impact to assay performance, however, outside of this range, a bias of greater than 3% may be seen with patient results. For US customers the Product Recall Letters were sent via FedEx Priority Overnight Express (note-for OUS, each country organization will establish their own method of notification, which consistence of mailings or customer visits). The Product Recall Letter instructed customers to: - Immediately discontinue use of the calibrator lot number and switch to the alternate calibrator lot. - Destroy any remaining inventory of impacted material according to customer's laboratory procedures. - Review this letter with Medical Director or Laboratory Management and follow laboratory protocol regarding the need for reviewing previously reported patient results. - Complete and return the Customer Reply Form. Contact your local firm representative for assistance with replacement product. - If customers have forwarded the product to other laboratories, please inform them of this Product Recall and provide them with a copy of this letter. - Please retain this letter for your laboratory records. If any health care providers have any questions regarding this information, U.S. Customers please contact Customer Service at 1-877-4ABBOTT (available 24 hours a day, 7 days a week). Customers outside the U.S., please contact your local area Customer Service. If any patient or user injury are experienced associated with this Field Action, please immediately report the event to your local area Customer Service.
Emerald Diluent Tubing, List number 09H50-01, accompanying CELL-DYN Emerald instrument, List number 09H39-01. The firm name on the label is Abbott Laboratories, Abbott Park, IL.
The diluent tubing used on the instrument appears cloudy or to have a powder/film on the inner and outer surfaces which may result in falsely elevated platelet results.
The recalling firm issued letters on 5/9/2019 to the consignees who had the installed instruments with the affected serial numbers. The letters were issued via FedEx priority overnight express.
ARCHITECT C Peptide Reagent - Product Usage: used as an aid in the diagnosis and treatment of patients with abnormal insulin secretion including diabetes mellitus.
Error in the renewal documentation process for license in Mexico. All in date ARCHITECT C Peptide Reagents, Calibrators and Controls are being recalled until a new license is obtained.
Abbott Laboratories notified customers on about 04/01/2020 via Product Recall letter. Instructions included to discontinue use and destroy any inventory of ARCHITECT CPeptide Reagents, Calibrators and Controls listed in the table above according to laboratory procedures. Instructions also included to complete and return the Customer Reply Form and to notify customers if product is further distributed.
ARCHITECT Sirolimus Calibrators - Product Usage: The ARCHITECT Sirolimus Calibrators are for the calibration of the ARCHITECT iSystem when used for the quantitative determination of sirolimus in human whole blood.
Devices were delivered without the required dry ice.
On about 04/04/2019, Abbott notified customers in Latvia of the recall. Instructions included to examine inventory for any affected devices on hand, review the letter with your Medical Director or Laboratory Management and follow your laboratory protocol regarding the need for reviewing previously reported patient results, complete and return the Customer Reply form, and notify customers if the affected devices have been forwarded to other laboratories and provide them a copy of the notification letter. If replacement material is available, customers were instructed to discontinue the use of affected devices and destroy any remaining inventory according to your laboratory procedures. If replacement material is not available, immediately order replacement material. Abbott instructed customers that they may continue to use the impacted material as long as controls are within range. Destroy impacted material once replacement material is available.
ARCHITECT SHBG Reagent The ARCHITECT SHBG assay is a chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of sex hormone binding globulin (SHBG) in human serum and plasma on the ARCHITECT iSystem. The ARCHITECT SHBG assay is used as an aid in the diagnosis of androgen disorders.
Firm has identified that ARCHITECT SHBG results generated with the Potassium EDTA specimen tube type may demonstrate a negative shift relative to results generated with serum. There is a potential for falsely decreased ARCHITECT SHBG results to be generated when using the ARCHITECT SHBG assay with the Potassium EDTA specimen tube type.
Abbott sent an Product Correction ( Immediate Action Required ) letter dated April 18, 2017, to all affected customers (with a response form) shipped via FedEx. Customers were instructed to discontinue use of the Potassium EDTA specimen tube type with the assay. All impacted US consignees were requested to return a customer reply form acknowledging that all the necessary actions, letter, were understood and completed. All impacted distributors were required to provide signed attestation ensuring that all their affected customers were sent the product correction letter informing them of this issue. Remaining inventory, at the firm's distribution centers, will have labeling corrected by inserting a kit stuffer informing customers that Potassium EDTA specimen tube type should not be used and providing customers will the recommend specimen types. If you or any of the health care providers you serve have any questions regarding this information, U.S. Customers please contact Customer Service at 1(877) - 4ABBOTT (available 24 hours a day, 7 days a week). Customers outside the U.S., please contact your local area Customer Service.
The ARCHITECT Estradiol Kit Intended to measure estradiol, an estrogenic steroid, in plasma.
Interaction of Fulvestrant with the ARCHITECT Estradiol assay, leading to falsely elevated estradiol results in patients treated with Fulvestrant.
The firm sent a Product Correction letter dated 3/24/2016 to all affected consignees describing the nature of the recall as well as instructions to follow. The necessary actions included the following: Consignees are asked to review the letter with their Medical Director. Patients undergoing Fulvestrant therapy should not be tested with the ARCHITECT Estradiol assay. Complete the Customer Reply Form. If the consignee has forwarded the product listed to other laboratories, a copy of Product Correction letter should be provided to them. The customer is asked to retain the letter for their laboratory records. Customers with questions should contact either Customer Service at 1-877-4ABBOTT for the US; or, the local area customer service for outside of the US.
CELL-DYN Ruby System: List Number: 08H6701; Hematology: The CELL-DYN Ruby System is a multi-parameter automated hematology analyzer designed for in-vitro diagnostic use in clinical laboratories
The Pump Relay Printed Circuit Board Assembly (PCBA) used in the CELL-DYN Ruby instrument may prematurely fail and lead to instrument stoppage
Product correction letters were sent to all affected customers on February 13, 2017 by traceable method. Letters provided information on the reason for the correction with all affected serial numbers listed. Abbott will be contacting each location to schedule replacement of the PCBA Pump Relay Board. Update: five additional serial numbers were added. Correction letters were sent to new consignees - 3 in Brazil and 2 in Mexico.
ARCHITECT Lactic Acid Part # 09D891T21 The Lactic Acid assay is used for the quantitation of lactic acid in human plasma.
Abbott has identified negative interference from the drug N-Acetyl Cysteine (NAC) with the ARCHITECT Lactic Acid reagent (LN 9D89-21).
Abbott Laboratories sent an Product Correction Immediate Action Required letter dated October 10, 2016, to all affected customers. Please review this letter with your Medical Director Taking the above information into consideration, you may continue to use ARCHITECT Lactic Acid reagent (LN 9D89-21) Please complete and return the Customer Reply Form If you have forwarded the product listed above to other laboratories, please inform them of this Product Correction and provide to them a copy of this letter Please retain this letter for your laboratory records. If you or any of the health care providers you serve have any questions regarding this information, U.S. Customers please contact Customer Service at 1-877-4ABBOTT (available 24 hours a day, 7 days a week). Customers outside the U.S., please contact your local area Customer Service. For further questions please call (847) 937-2550.
CELL-DYN Emerald Cleaner, product number 09H46-02. 960mL. IVD; Hematology: The CELL-DYN Emerald Cleaner is designed for use on the CELL-DYN Emerald System, which is an automated hematology analyzer designed for in-vitro diagnostic use in clinical laboratories. The CELL-DYN Emerald Cleaner is an enzymatic cleaner used to clean the measurement system and the fluidics.
Three lots of CELL-DYN Emerald Cleaner may have occurrences where the analyzer generates Quality Control Out of Range Low for parameters RBC and PLT.
All customers who were shipped the affected lots were sent a Product Recall letter on March 24, 2016 via Federal Express. Letters were titled Product Recall - Immediate Action Required. An additional four lots were discovered to be affected by the recall and the firm send letters to customers affected by these lots on June 27, 2016
HbA1c Calibrators LN 4P52-02 consists of: 4P52-02 Hemoglobin A1c 1 x 1.6 mL and 1 x 1.6 mL. A1c Calibrators (lyophilized) contain hemoglobin and glycated hemoglobin from human whole blood. Prior to lyophilization, the calibrator matrix is an MES-buffered solution. Preservative: Ofloxacin. For use in the calibration of the Hemoglobin A1c assay on the ARCHITECT c 8000 and c 4000 Systems.
HbA1c Calibrators LN 4P52-02, lot 45063UQ12 may contain a value sheet for a different HbA1c calibrator lot. If calibrator lot 45063UQ12 is used in the calibration of the HbA1c assay using values from an incorrect calibrator value sheet then all results, including quality control and patient, may be falsely elevated.
Product Correction letters dated April 30, 2014 were sent to all customers. The letters included isntructions for customers to: 1) verify that the lot numbr listed on each calibrator bottle agrees with the lot number printed on the value sheet; 2) If HbA1c Calibrators lot 45063UQ12 has already been utilized in your laboratory, verify the concentrations configured for this calibrator lot match the values in the letter; 3) If these do not match, use the values in the letter when calibrating the HbA1c assay using calibrator lot 45063UQ12; and, 4) follow your laboratory protocol regarding the need for reviewing previously reported patient results if incorrect calibrator values were used.
ARCHITECT CA 19-9XR Reagent Kit; ARCHITECT CA 19-9 Reagent Kit, list 291-20 (4 x 100 tests), 2K91-25 and 2K91-27 (1 x 100 tests); Product Usage: The ARCHITECT CA 19-9XR assay is a chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of 1116-NS-19-9 reactive determinants in human serum or plasma on the ARCHITECT i System. The ARCHITECT CA-19-9XR assay is to be used as an aid in the management of pancreatic cancer patients in conjunction with other clinical metho
The six ARCHITECT CA 19-9XR reagent lots are demonstrating a shift up in patient results. The Abbott Controls however do not detect the upward shift and will test within range.
The firm, Abbott Laboratories, sent a "Product Recall Immediate Action Required" letter dated May 30, 2012 to all Architect CA 19-9XR customers who received the affected reagent lots. The customers were directed to immediately discontinue use and destroy any remaining inventory of the lots listed; to review the patient results obtained with the affected lots with the treating physician or heath care provider to ensure they are aware of the potential analytical issue and can determine whether re-evaluation of the patient is necessary; to forward a copy of the letter to any laboratory to whom they may have forwarded the reagent; and to retain a copy of the letter for their records and to complete and return the Customer Reply Form via fax to: 1-800-777-0051 or e-mail: QAGCO@abbott.com. For questions were call your local Customer Service representative or call the field action coordinator at 847-938-1923.