Abbott Laboratories Recalls
Showing 121-140 of 153 recalls
Abbott AxSYM Cancer Assay Disk Version 5.0, for in vitro diagnostic use with the AxSYM System; Abbott Laboratories, Abbott Park, IL 60064; List Number 3D50-05. AxSYM AFP is a Microparticle Enzyme Immunoassay (MEIA) for the quantitative determination of alpha-fetoprotein (AFP).
The AxSYM Cancer Assay Disk (LN 3D50-05 version 5.0) contains an AxSYM AFP assay file where the Low Concentration flag for the AFP 1:101 automated dilution protocol the instrument to report results between 0 ng/mL and 0.4 ng/mL (40.4 ng/mL accounting for the 1:101 dilution). The sensitivity of the assay is 0.4 ng/mL.
Abbott sent "Product Correction Immediate Action Required" letters dated February 2, 2009 to all AxSYM AFP customers. Customers were requested to install the updated version of the AxSYM AFP assay using version 6.0 of the AxSYM Cancer Assay Disk provided with the letter and to retain a copy of this communication for their records. Any questions regarding the letter were directed to Customer Service at 1-877-4ABBOTT.
AxSYM System Tubing Decontamination Solution; 500 mL bottle; Abbott Laboratories, Diagnostics Division, Abbott Park, IL 60064; List Number 07B05-09. To be used only for cleaning and inhibition of fouling bacteria in the tubing system of the in vitro immunoassay analyzer. This product does not disinfect or sterilize the tubing system.
Bottle labels from lot 211974, AxSYM System Tubing Decontamination Solution (List Number 7B05-09), were found to be missing the following information: lot number, date of manufacture, and expiration date.
Abbott sent Product Recall Immediate Action Required letters dated February 18, 2009 to customers informing them of the affected product. Customers were instructed to examine their inventory and dispose all affected product. Accounts were requested to complete and fax back customer reply sheet acknowledging receipt of the letter, as well as the number of bottles destroyed, and to retain a copy of the letter for their records. For further information, contact Abbott Customer Service at 1-877-4ABBOTT.
ARCHITECT i1000SR System Assay CD ROM WW (excluding US) Special edition Version 1.01 and Version 2.0; list 01P61-01 and 01P61-02. The device is intended to duplicate manual analytical procedures by performing automatically various steps such as pipetting, preparing filtrates, heating, and measuring color intensity.
When running the Automated Dilution Protocol with the assay files "CMV IgG" or "Toxo IgG" on the ARCHITECT i1000SR system, a software error [9010 (Pipettor Robotics) preventing (Process Path) from operating] is generated and the instrument stops running. No results are generated.
Abbott affiliates were e-mailed copies of the recall letter Urgent Field Safety Notice Product Correction on 6/16/08 for translation where needed and dissemination to their ARCHITECT accounts who have the affected assay CD-ROMs. Each Abbott international organization will be responsible for contacting customers and determining the method of effectiveness checks based on their country requirements. Abbott sent Product Correction, Immediate Action Required letters dated June 16, 2008 to all active non-U.S. ARCHITECT customers who have the affected assay CD-ROMs. The end users were informed when running the Automated Dilution Protocol of the ARCHITECT CMV IgG and Toxo IgG assays on the ARCHITECT i1000SR System, software error code [9010 (Pipettor Robotics) preventing (Process Path) from operating] is generated and the instrument stops. The accounts were advised to not use the Automated Dilution Protocol of either the ARCHITECT CMV IgG and Toxo IgG assays on the ARCHITECT i1000SR System and report results for samples requiring dilution as ">250.0 AU/mL" for CMV IgG and ">200.0 IU/mL" for Toxo IgG until a corrected version of the ARCHITECT i1000SR System Assay CD-ROM is available in late September 2008. The accounts were requested to keep a copy of the letter on file. The accounts were requested to complete the customer reply form, indicating that the letter was received, understood and disseminated to the laboratory manager/supervisor responsible for Architect testing, and fax it to Abbott by 7/1/08 at 1-800-777-0051. If you have question, contact your local area Customer Support.
Architect LH MasterCheck (List 6C25-05). An in-vitro diagnostic, consisting of 4 - 2 mL vials of LH MasterCheck, Levels 0, 1, 2 and 3. Manufactured for Abbott Laboratories, Abbott Park, IL 60064. ARCHITECT LH MasterCheck is intended for use in the verification of sensitivity, calibration linearity, and reportable range of the LH assay on the Abbott ARCHITECT i System.
The values listed in the Architect LH MasterCheck, Lot 82520 data sheet are incorrect. When MasterChecks do not perform as intended, the integrity of the system cannot be verified and patient results would not be generated. Other commercially available materials are available to customers in order to meet CLIA requirements.
A Product Correction, Immediate Action Required letter and Customer Reply Form dated 9/5/08 were sent to all Architect LH MasterChecks (List Number 6C25-05) customers who received Lot 82520M. Customers were informed that the values listed in the Architect LH MasterCheck Lot 82520 data sheet are incorrect. Customers were requested to check their inventory for the affected lot, and if any kits were found, to substitute the values printed on the data sheet with the values supplied in the letter. In addition, Customers were requested to keep a copy of the letter on file and to complete the Customer Reply Form, indicating that the letter was received, understood and disseminated to the laboratory manager/supervisor responsible for the Architect LH MasterCheck testing, and fax it to Abbott by 9/19/08 at 1-800-777-0051. Follow-up telephone calls will be placed to customers who do not provide a written reply via the Customer Reply Form. U.S. Customers please contact Abbott Laboratories Customer Service at 1-877-422-2688 for questions regarding this information.
CELL-DYN Sapphire Hematology Analyzer, List number 08H00-01, LIS/ Middleware Interface Specification, Abbott Diagnostics Division, Santa Clara, CA For in vitro diagnostic use in counting and characterizing blood cells.
Table in LIS Specification depicting the association between Record ID and Numerical Result Label is incorrect. If a record ID is used to configure the system for mapping, results will come out nonsensical.
Recall initiated on April 11, 2008. A Product Correction letter and customer reply form were sent to all currently active CELL-DYN Sapphire Customers. The letter requests that users be certain that the transmission of test results receipt by the host interface is mapped according to the Numerical Result Label, when configuring their CELL-DYN Sapphire Hematology Analyzer for results transmission to a Clinical Laboratory Information System or Middleware. Affected product was distributed to a total of 4 distributors. However, notification was made to all 154 customers that received the CELL-DYNE Sapphire product. If the customer or the health care providers that they serve have any questions regarding this information, U.S. customers should call Customer Support at 1-877-4ABBOTT.
AxSYM Drugs of Abuse/Toxicology Assay Disk Version 8.0; List Number: 3D54-08; Abbott La boratories, Diagnostics Division, Abbott Park, IL 60064
Error Message: If the Positive and Negative Interpretation Cutoff parameters (116/117) are edited after installation of the revised assay file, VRTX error #0002 in Task 40 is generated and the instrument locks up when it attempts to report an AxSYM Amphetamine/Methamphetamine II patient result.
Consignees were sent a Product Correction-Immediate Action Required letter on 1/21/08. The letter provided users with the steps to take to temporarily correct the problem until the recalling firm is able to send a corrected assay file. Users were requested to return a customer reply letter acknowledging receipt of the letter. For additional information, contact 1-877-4ABBOTT.
ARCHITECT i System Assay CD ROM - US, list 6E58-22, Version 22.01, and ARCHITECT i System Assay CD-ROM - WW (excluding US), list 6E59-23, Version 23.0, containing the ARCHITECT LH assay file; Abbott Laboratories, Diagnostic Division, Abbott Park, IL 60064 USA; Product List Number: 6E58 (US) and 6E59 (WW) Versions 23 and lower. The Architect LH assay is a Chemiluminescent Microparticle Immunoassay for the quantitative determination of human luteinizing hormone (LH) in human serum or plasma.
There continues to be an elevated level of complaint activity for calibration error code 1227, when using ARCHITECT LH reagent lots (6C25-22 or 6C25-27) due to the use of assay disk versions that do not contain the updated ARCHITECT LH assay file contained on ARCHITECT i System Assay CD ROM versions 24 and higher (US LN 6E58, WW LN 6E59).
Abbott issued a "Product Correction-Immediate Action Required" letter dated April 24, 2009. The letter provided users with the steps to take to determine what version of the ARCHITECT LH Assay is on their instrument and instructions for installing the assay file provided with the letter if needed. Users were requested to return a customer reply letter acknowledging receipt of the letter. For additional information, contact 1-877-4ABBOTT.
Abbott Diagnostics CELL-DYN Sapphire Hemoglobin Reagent Analyzer Syringes, List Number 08H49-02, Abbott Laboratories, Abbott Park, IL (the syringe is packaged in a white box and sealed with a label wrapped around the center of the box-The main analyzer list number is 08H00-01, )
Syringe Failure: Insufficient lubrication of the plunger tip may cause syringes to fail at installation or shortly thereafter
This Recall was initiated 07/24/07 via a Product Recall letter-Immediate Action Required-instructing users to discontinue use and destroy any units under recall. Replacements may be obtained by contacting the local Customer Support Center at 1-877-4Abbott
ARCHITECT i System Assay CD-ROM - WW (excluding USA accounts), Versions prior to Version 24.0; for use on the ARCHITECT i System; List Number (LN) 6E59,Abbott Laboratories, Diagnostics Division, Abbott Park, IL 60064 USA
The lower limit flag for auto-dilution protocol 3 (amniotic fluid) was set too low (15 ng/mL) for the ARCHITECT AFP assay file for the ARCHITECT AFP non-U.S. product. The assay labeling indicates that the limit flag should be set no lower than 20 ng/mL
Abbott affiliates were e-mailed copies of the Product Correction (Immediate Action Required) Recall Letter on 9/18/07 for translation where needed and dissemination to their ARCHITECT accounts who have the affected assay CD-ROMs. Each Abbott international organization will be responsible for contacting customers and determining the method of effectiveness checks based on their country requirements. Abbott sent Product Correction, Immediate Action Required letters dated 18 September 2007 to all active non-U.S. ARCHITECT customers who have the affected assay CD-ROMs. The end users were informed that current AFP file has been updated on a new ARCHITECT I Assay CD-ROM (LN 6E59, version 24). The Low-Linearity flag threshold for the Amino 1:50 dilution has changed from 15 ng/mL to 20 ng/mL for consistency with overall assay sensitivity. The accounts were advised to install the updated version of the current ARCHITECT AFP assay when they receive the version 24 ARCHITECT I Assay CD-ROM. The accounts were requested to keep a copy of the letter on file. The accounts were requested to complete the customer reply form, indicating that the letter was received, understood and disseminated to the laboratory manager/supervisor responsible for Architect testing, and fax it to Abbott by 9/28/07 at 1-800-777-0051.
Architect Free T4 MasterCheck; a single (specified) analyte control (assayed and unassayed); list 6C50-05. Intended for use in the verification of sensitivity, calibration linearity, and reportable range on the Abbott ARCHITECT i System. Abbott Laboratories, Abbott Park, IL 60064
Testing material becomes unstable at the recommeded storage temperature. Some of the Architect Free T4 MasterCheck and Total T4 MasterCheck lots are not stable at the recommended storage condition of 2 to 8 degrees Celsius through expiration dating. These lots may exceed the suggested tolerance limits listed in the Reportable Range/Calibration Verification section in Appendix B of the Architect
Abbott sent a Product Recall letter dated 2/27/08, to all customers who received the affected product lots, informing them that the storage conditions are being changed to -10 degrees C or colder for all lots of material manufactured after lot numbers 82130M and 84110M until the cause has been determined and a corrective action has been implemented. All new shipments will contain additional instructions indicating that the ARCHITECT Free T4 and Total T4 MasterChecks are to be stored frozen until first use. Customers were requested to check their inventory for lot numbers 82130M and 84110M, discontinue use of the lots and destroy any remaining inventory. For lots 82140M, 82150M and 84120M, if they know the date the lot was received or the date it was thawed, they may continue to use lots if they have been stored at 2 to 8 degrees C unopened for less than 60 days. If the material has been stored at 2 to 8 degrees C for greater than 60 days or they do not know the number of days it has been thawed, they were instructed to discard the material. They were requested to forward a copy of the letter to any laboratory to whom they may have forwarded the kits. Any questions were directed to Abbott Customer Support at 1-877-4ABBOTT in the U.S. Customers outside of the U.S., were requested to contact their local customer support representative.
AxSYM Rubella IgG Reagent Pack; Abbott Laboratories, Abbott Park, IL 60064; list 3B23-20 The AxSYM Rubella IgG assay is a Microparticle Enzyme Immunoassay (MEIA) for the quantitative and qualitative measurement of IgG antibodies to rubella virus in human serum or plasma (EDTA, heparin or sodium citrate) to aid in the determination of immune status to rubella.
An increase in complaints was noted for AxSYM Rubella IgG assay calibration failures due to error codes related to elevated Calibrator A (or Master Calibrator 1) rates too high.
Consignees were sent a Product Correction-Immediate Action Required letter on 6/2/08. The letter informed users of calibration failures due to elevates Calibrator A or Master Calibrator 1 rates when attempting to calibrate the AxSYM Rubella IgG assay and that they must clarify the Rubella IgG Calibrator A or the Rubella IgG Master Calibrator 1 and the Rubella IgG Negative Control by centrifugation at >/= 10,000 x g for 10 minutes prior to testing. Users were requested to return a customer reply letter acknowledging receipt of the letter. For additional information, contact Abbott Labs at 1-877-4ABBOTT.
10 French Ross Flexiflo Lap J Laproscopic Jejunostomy Kit with Brown/Mueller T-F Fastener Set (list #51442).
The kits contain a 12 Fr. Introducer Tear-Away BNS component . The manufacturer of the component B. Braun Medical Inc., Allentown, PA notified Abbott Laboratories by letter dated 5/27/05, that the tearaway introducer sheaths may have cracked hubs/handles and/or improper peeling of the sheath during use in a small percentage of the affected lots.
The recalling firm sent a device correction recall letter dated 6/16/05 by overnight courier to all consignees.
White Blood Cell (WBC) Reagent-Part A used with the CELL-DYN 4000 and CELL-DYN Sapphire Systems, Red cell lysing reagent, List Number 01H77-01, Supplied in 3.8L bottles, Abbott Laboratories, Abbott Park, IL 60064
Microbial Contamination: The WBC (White Blood Cell) Reagent Part A was confirmed positive for Pseudomonas contamination.
Consignees were notified by a Product Recall letter sent 12/19/07. The letter instructs users to discontinue use of affected product and destroy any remaining inventory. Users were requested to return a customer reply form. For additional information, contact 1-877-4ABBOTT.
Abbott CELL-DYN 3000 Hematology Analyzer
The product failed electrostatic discharge testing, which could result in product failure.
Mandatory Technical Service Bulletins (TSB) are being issued to Field Service to upgrade all instruments in the field. All customers will be contacted by Field Service to schedule this mandatory upgrade. The upgrades are expected to take 12 months.
ARCHITECT Prolactin MasterCheck; a single analyte control - each kit contains 1 - 2 mL bottle of Architect Prolactin MasterCheck Level 0 containing HEPES buffer with protein (bovine) stabilizers, and 4 - 2 mL bottles of Architect Prolactin MasterCheck Levels 1, 2, 3 and 4 containing prolactin (human) prepared in HEPES buffer with protein (bovine) stabilizers; Abbott Laboratories, Abbott Park, IL 60064, list 6C27-05
The Architect Prolactin MasterChecks may not be stable at the recommended storage conditions of 2 to 8 degrees C through the expiration dating (15 months). The MasterChecks may exceed the suggested tolerance limits listed in the Reportable Range/Calibration Verification section in Appendix B of the Architect iSystem Operations Manual.
Abbott sent a Product Correction letter dated 7/6/07, to all customers who received the affected product lot, informing them that the ARCHITECT Prolactin MasterChecks may not be stable at the recommended storage condition of 2 to 8 degrees Celsius (C) through expiration dating (15 months). Labeling is being permanently updated to indicate that ARCHITECT Prolactin MasterChecks are to be stored frozen until first use. After thawing, ARCHITECT Prolactin MasterChecks can be stored unopened at 2-8 degrees C for thirty days or until expiration which ever occurs first. All future shipments will contain updated storage and handling conditions of the ARCHITECT Prolactin MasterCheck. They were requested to check their inventory to see if they have any remaining inventory of lot number 82900M. If they know the date the lot was received or the date it was thawed, they may continue to use the ARCHITECT Prolactin MasterChecks if it has been stored at 2 to 8 degrees C unopened for less than 30 days. If the material has been stored at 2 to 8 degrees C for greater than 30 days or they do not know the number of days it has been thawed, they were instructed to discard the material. Reimbursement for discarded kits will be provided based on information provided in the Customer Reply form. Until labeling is updated, it will be necessary to use an alternate material for verification of sensitivity, calibration linearity, and the reportable range of the ARCHITECT Prolactin assay. They were requested to forward a copy of the letter to any laboratory to whom they may have forwarded the kits, and to retain a copy of the letter for their records. Any questions were directed to Abbott Customer Support at 1-877-4ABBOTT in the U.S. The accounts were requested to complete and fax back the customer reply form, acknowledging the receipt and understanding of the correction letter. Customers outside of the U.S., were requested to contact their local customer support representative.
AxSYM Troponin-I ADV Reagent Pack; list 02J44; 100 test pack; in-vitro diagnostic; Abbott Laboratories, Abbott Park, IL 60064
Failure of the AxSYM instrument to open (actuate) some reagent packs from certain lots. The defects can result in probe crashes if not detected prior to placement of the reagent kit on the AxYM instrument.
Abbott initiated a field correction recall by letter dated 4/23/07 to all customers receiving the affected reagents. The accounts were informed of the failure of the AxSYM to open (actuate) some reagent packs with the affected lots. The accounts were requested to inspect each reagent pack for broken or improperly sealed caps; manually open each bottle to ensure the flipper bar raises the reagent cap correctly; close each flipper bar prior to loading the reagent pack on the instrument; and discard any reagent packs that do not open properly. If the user observes a probe crash, prior to testing samples again, the user must perform a probe crash recovery following the procedure in the Operations Manual. If necessary, they need to replace the probe. If a probe crash recovery is not performed, subsequent results may be impacted. The customers were requested to retain a copy of the letter for their records. Customers requiring additional information were directed to contact Abbott Customer Service at 1-877-422-2688.
Abbott AxSYM AUSAB Reagent Pack, List No: 3C74-20, 100 tests, an in-vitro test for Antibody to Hepatitis B Surface Antigen (Anti-HBs); Abbott Laboratories, Abbott Park, IL 60064
Incorrect results: Reagents in these lots were manufactured with an incorrect ratio of 2 key components, which could result in both false reactive and false nonreactive specimens.
Abbott sent a Product Recall letter, dated 10/01/07, to all AxSYM AUSAB customers that received the affected lots of product, informing them of the manufacturing error that resulted in both false reactive and false nonreactive specimens. The letter provided the assay bias for both lots. The accounts were requested to examine their inventory for the affected lots; destroy any packs found; record the number of packs destroyed on the Customer Reply Form; and fax the completed form back to Abbott at 1-800-777-0051 prior to 10/12/07. They were also requested to evaluate patient results generated with these lots in alignment with the information provided in the letter to determine if additional action is necessary. They were requested to forward a copy of the letter to any laboratory to whom they may have forwarded the lots; and to retain a copy of the letter for their records. Any questions were directed to Abbott Customer Support at 1-877-4ABBOTT.
ARCHITECT Estradiol Reagent, each kit contains bottles of coated Microparticles and bottles of Conjugate; 400 Test Kit-list number 2K25-20 (4 x 100 tests) and 100 Test Kit-list number 2K25-25 (1 x 100 tests); Abbott Laboratories, Abbott Park, IL 60064-3500
A small number of reagent kits were incorrectly configured. The affected kits contain either two bottles of conjugate or two bottles of assay diluent instead of one bottle of each.
Abbott initiated a field correction recall by letter dated 2/19/07 to all customers receiving the affected reagent. The accounts were informed of the incorrectly configured reagent kits. The accounts were requested to assess the inventory for the affected lots of reagents, inspect each kit and destroy any kits incorrectly configured, recording the number of kits inspected and the number of kits discarded on the customer reply form and faxing it to Abbott by 3/2/07, indicating that the letter was received and understood. Replacement kits will be issued for the number of kits destroyed, as indicated on the reply sheet. Customers requiring additional information were directed to contact Abbott Customer Service at 1-877-422-2688.
CELL-DYN Sapphire and CELL-DYN 4000 Diluent/Sheath Systems- List No. 01H73-01, Distributed and Manufactured by: Abbott Diagnostics Division, 5440 Patrick Henry Drive, Santa Clara, CA
High platelet background count when using the CELL-DYN 4000 System and/or CELL-DYN Sapphire System; with patient results unacceptable -out-of-range.
On 4/17/06, the firm initiated the recall and its notification letters explained the reason for the recall and reported Abbott Field Service personnel will install and replace filters at all recall sites
CELL-DYN Diluent/Sheath Reagent, for use with CELL-DYN Ruby, Sapphire and 4000 systems. List #01H73-01. Packaged in 20 Liter cubitainers.
Results for tests of RBC, MCV, RDW, MPV and PLT may be falsely elevated or falsely decreased when the Cell Dyn Diluent/Sheath reagent is used with Cell-Dyn 4000, Ruby and Sapphire systems.
Recall initated 12/22/2006. Product letters were sent to consignees, as well as a customer reply form. The letters were sent with customer reply forms. Responses will be tracked via the response forms included with letters.