Roche Diagnostics Corporation Recalls
Showing 1-20 of 26 recalls
Roche Diagnostics URISYS 1100 Urine Analyzer Part Number: 03617556001 Product Usage: The URISYS 1100 Urine Analyzer is a reflectance photometer designed to automatically read and evaluate the results of Chemstrip 5 OB, Chemstrip 7, Chemstrip 10 MD, and Chemstrip 10 UA urine test strips for various urine analytes.: specific gravity, pH, leukocytes, nitrite, protein, glucose, ketones, urobilinogen, bilirubin and blood
Limits of Detection (LoD) for protein, nitrite, leukocytes, and erythrocytes on the Urisys 1100 urine analyzer with Chemstrip 5 OB, Chemstrip 7, Chemstrip 10 MD, and Chemstrip 10 UA test strips were higher than what is listed in the test strip method sheets may lead to false negative results for the affected parameters
Roche Diagnostics notified Consignees by the Urgent Medical Device Correction (UMDC) sent UPS Ground (receipt required) on 9/24/18. For consignees associated only with a PO number address, the UMDC will be sent by USPS mail. Consignee Instructions: 1. When using Chemstrip 5 Ob and/or Chemstrip 7 test strips, results should only be read visually. These test strips can no longer be read on the Urisys 1100 urine analyzer. Follow the directions in the Instructions for Manually Reading Chemstrip test Strip results section of the UMDC. 2. When using Chemistrip 10 MD or Chemstrip 10 UA test strips: You can choose to read the test strips visually or If you continue to use the strips with the Urisys 1100 urine analyzer, a negative result for any of the four affected parameters (protein, nitrite, leukocytes, and erythrocytes) must be repeated with a new test strip that is read visually. Follow the directions in the instructions for Manually Reading Chemstrip Test Strip Results section of the UMDC. 3. If you are unable to implement the visual read-only method for Chemstrip 5 OB, Chemstrip 7, Chemstrip 10 MD, or Chemstrip 10 UA test strips: Dispose of the affected test strip vials per local guidelines. Contact your distributor partner for credit. 4. Complete all sections of the enclosed fax back forms Contact Roche Diagnostics Point-of-Care Technical Service, 24 hours a day, seven days a week at 1-800-428-4674 if you have questions
Bilirubin Total Gen.3, Cat. Nos. 05795397190, 05795419190, 05795320160, 05795338160, 05795346160 ***added as of 5/10/19***05795397190, 05795648190 Product Usage: In vitro test for the quantitative determination of total bilirubin in serum and plasma of adults and neonates on Roche/Hitachi cobas c systems.
New endogenous interference claims have been established for the following assays used on the cobas c 311 analyzer and the cobas c 501, 502, 701, 702, and Modular Analytics P/D modules which may have potential medical risk. ***Update: Cobas c111 and COBAS INTEGRA 400 plus analyzers are also impacted for BILT3 and LACT2 assays***
On 12/17/18, the firm distributed an Urgent Medical Device Correction letter to affected consignees. Customers were notified of the interference issues. The Limitations-interference section of the method sheets for the cobas c 311 analyzer and the cobas c 501, 502, 701, and 702 modules are being updated with the following claims: Bilirubin Total Gen.3 assay: Immunoglobulins: No significant interference from immunoglobulins up to a concentration of 28 g/L (187 mol/L) (simulated by human immunogloblulin G). Lactate Gen.2 assay (CSF samples): Ditaurobilirubin: No significant interference from ditaurobilirubin up to an approximate concentration of 102 mol/L (6 mg/dL). Tina-quant IGM-2 (Sensitive application): Hemolysis: No significant interference up to an H index of 600 (approximate hemoglobin concentration of 373 mol/L or 600 mg/dL). Lipemia (Intralipid): No significant interference up to an L index of 600 Customers were asked to do the following: " Be aware of the new interference claims listed in this Urgent Medical Device Correction (UMDC). This UMDC serves as labeling until the updated method sheets are available. The method sheets for the MODULAR ANALYTICS P/D modules will not be updated. " Manually update the H and L indexes for the IGMP2 sensitive application on your cobas c 311 analyzer or cobas c 501, 502, 701, and 702 modules following the instructions provided in this UMDC. " Complete all sections of the enclosed fax form (TP-00507) and fax it to 1-xxx-xxx-xxx or email it to rochexxxx@stericycle.com. " File this UMDC for future reference. When the method sheets are updated, they will be available on the diagnostics.roche.com Please contact the Roche Support Network Customer Support Center, 24 hours a day, seven days a week at 1-800-428-2336 if you have questions. website and on the cobas e-library. ***UPDATE: Firm sent updated communication to customers dated 5/9/2019 informing them that L and H index values
CoaguChek XS System Prothrombin time test: CoaguChek XS PT Test 2X24 Strips, Catalog Number: 04625315160; CoaguChek XS PT Test 6 Strips, Catalog Number: 04625374160; CoaguChek XS PT Test 24 Tests, Catalog Number: 07797826160;
Abnormally high INR test results with the affected CoaguChek test strips
Roche issued URGENT MEDICAL DEVICE RECALL AMENDMENT letters dated 11/5/18 advising customers patients, HCPs, IDTFs, HCP distributors and HCP/patient distributors. Distributors are advised to take the following actions: - Read the Urgent Medical Device Recall Amendment for Healthcare Professionals and Clinics Furnishing PT/INR Test Strips to Patients for Home Testing Use (TP-00454). - Distribute a copy of the Urgent Medical Device Recall Amendment TP-00454 to healthcare professionals to whom you have directly shipped affected test strips. - Stop distribution of all affected CoaguChek XS PT Test Strip lots. - Complete all sections of the fax form (TP-00462) and fax it to number 1-888-627-2279 or email it to roche3866@stericycle.com. - Return all affected product following the instructions outlined in this Urgent Medical Device Recall Amendment. Independent Diagnostic Testing Facilities should take the following action: - Read the Urgent Medical Device Recall Amendment for CoaguChek Patients (TP-00453) and Urgent Medical Device Recall Amendment for Healthcare Professionals and Clinics Furnishing PT/INR Test Strips to Patients for Home Testing Use (TP-00454). - Distribute a copy of the Urgent Medical Device Recall Amendment for CoaguChek Patients (TP-00453) to your CoaguChek patient self-testers. - Distribute a copy of the Urgent Medical Device Recall Amendment for Healthcare Professionals and Clinics Furnishing PT/INR Test Strips to Patients for Home Testing Use (TP-00454) to your Healthcare Professional customers. - Stop distribution of all affected CoaguChek XS PT Test Strip lots. - Complete all sections of the fax form (TP-00461) and fax it to number 1-888-627-2279 or email it to roche3866@stericycle.com. - Return all affected product following the instructions outlined in the Urgent Medical Device Recall Amendment. Healthcare Professionals and Clinics Furnishing test strips to Patients for Home Use should take the following action: - Stop usin
Cobas infinity central lab IT solution Material Number: 07154003001 Calculator/Data Processing Module, For Clinical Use
Using the following versions of cobas infinity software (2.0 thorough 2.5), there is a potential where the results from the first sample subsequent to the bottle change, (when using the Standby bottle function), does not display a quality control (QC) alarm when one should be present. If the QC is out of range on the stand-by bottle and it is not removed from the system, there is a potential that when the status of the Standby bottle changes from the Standby bottle to the Current bottle status, QC alarms will not be displayed next to the sample result.
Roche Diagnostics issued on 2/04/19 an "URGENT MEDICAL DEVICE CORRECTION"(UMDC) letter to its customers via UPS Ground (receipt required). The letter describes the product, problem and actions to be taken. The customers were instructed to do the following: " When using the automated bottle change function, ensure Good Laboratory Practices (GLP) are being followed (i.e., all QC results for the current and standby bottles are in range and are not flagged prior to testing patient samples). " Complete the attached fax form (TP-00548) and fax this form to 1-866-608-3939 or email it to Roche10042@stericycle.com. " When a new software version is available, a Roche representative will contact you to schedule the software update. " File this UMDC for future reference. Contact the Roche Support Network Customer Support Center 24 hours a day, seven days a week at 1-800-526-2272 if you have questions
COBAS INTEGRA 400 plus analyzer used in the following assays: a)Tina-quant Apolipoprotein A-1 ver.2 Catalog Number: 03032566122 b)Tina-quant Albumin Gen.2 Catalog Number 04469658190 c)Creatinine plus ver.2 Catalog Number 03263991190 d) riglycerides Catalog Number :20767107322 - Product Usage: Tina-quant Apolipoprotein A-1 ver.2 A lipoprotein test system is a device intended to measure lipoprotein in serum and plasma. Lipoprotein measurements are used in the diagnosis and treatment of lip
COBAS INTEGRA 400 plus and cobas c 111 analyzers Additional Extra Wash Cycle Configurations and/or Batch Mode Needed for Specific Tests Due to Carry-over
Roche Diagnostics issued on 12/14/18 "Urgent Medical Device Correction (UMDC) via UPS Ground (receipt required) Consignee Instructions: Manually add the EWCs listed in the Urgent Medical Device Correction (UMDC) on your COBAS INTEGRA 400 plus and cobas c 111 analyzers. If customers run the test combinations requiring needle assignment (See Table on page 3 of UMDC TP-00508), run those in batch mode until the updated TAS has been loaded on the COBAS INTEGRA 400 Plus analyzer. Contact the Roche Support Network Customer Support Center, 24 hours a day, seven days a week at 1-800-428-2336 if you have questions.
Albumin BCP Product Usage: ALBP is an in vitro test used for the quantitative determination of albumin in human serum and plasma on Roche/Hitachi cobas c systems.
The reagent lot is exhibiting calibration failures, QC imprecision, and elevated QC recovery due to elevated pH level causing higher absorbance values.
Urgent Medical Device Correction notification letters dated 3/18/19 were sent to customers. The letter identified the affected product, problem and actions to be taken. The letter instructed customers to: Stop using and discard all Albumin BCP reagent cassettes from lot number 35651401 (catalog number 05975573190) remaining in your inventory according to your local guidelines. Actions Required " Complete all sections of the enclosed fax form and fax it to 1-833-254-2600 or email it to Roche10060@stericycle.com even if you are not requesting product replacement. " Discard remaining affected product in your inventory according to local guidelines. " File this Urgent Medical Device Correction (UMDC) for future reference.
The Tina-quant lgA Gen.2 is an immunoturbidimetric assay. Anti-lgA antibodies react with antigen in the sample to form an antigen/antibody complex which is measured turbidimetrically.
Calibration failures with Std.E, Sens.E, or Dup.E error due to atypical reaction kinetics and quality control failures have occurred due to contamination of R1 reagent with R3 reagent.
Urgent Medical Device Correction notification letters dated 6/3/19 were sent to customers.
Cobas 8000 Modular Series system; Software Version 05-02 and 06-03; UDI: 05641446001
A software failure may incorrectly set the system settings to "default" settings, creating a risk of incorrect results.
Consignees were notified by letter (receipt required) and requested to follow instructions to determine if the software issue has occurred. If the software issue is detected the consignee contacts customer support to have system reconfigured.
cobas p 501 post-analytical units, Part Number 05158494001. For diagnostic sample storage and retrieval.
There is a potential for the tray input flap on the post analytical units to become loose, potentially detaching from the instrument.
On April 4, 2019, Roche issued Urgent Medical Device Correction notices (UMDC TP-00620) to customers via UPS Ground (receipt required). Customers were advised to take the following actions: 1) Inspect the tray input flap on the cobas p 501 or p 701 post-analytical unit to determine if it is loose. If it is not fastened securely or becomes loose prior to the part being replaced, contact your Roche Field Engineer Specialist (FES) to repair the instrument. 2) Complete and return the fax form (TP-00621) via fax or email 3) File the UMDC for future reference. Customers with questions may contact the Roche Support Network Customer Support Center 24 hours a day, seven days a week at 1-800-428-2336 if you have questions about the information contained in the UMDC.
Elecsys Vitamin D total II, Vitamin D Test System, Material number 07028148190 Product Usage: This assay is intended for the quantitative determination of total 25-hydroxyvitamin D in human serum and plasma. This assay is to be used as an aid in the assessment of vitamin D sufficiency in adults. The electrochemiluminescence binding assay is intended for use on the immunoassay analyzer.
The device may give a falsely elevated result that is non-reproducible. If vitamin D level is monitored by laboratory tests and adapted based on the result, a dosage reduction of vitamin D supplementation cannot be excluded, and as a consequence, vitamin D deficiency may develop over time.
On April 27, 2018, the firm issued an Urgent Medical Device Correction letter to all affected customers. The letter advised customers in the following workaround to improve sample quality prior to measurement with the Elecsys Vitamin D total II assay. The firm stated these steps are to be carried out temporarily until further information is provided: 1. Perform a thorough inspection of your pre-analytical handling to ensure a correct assay performance of Elecsys Vitamin D total II and to comply with the individual specifications of the primary tube manufacturers for all tubes in use (centrifugation conditions are particularly important as well as the elimination of foam/bubbles from the surface of the sample). 2. If the issue persists, switch from plasma to serum. 3. If you still encounter the issue for plasma or serum, re-centrifuge the sample in a secondary tube for 10 minutes at 2000 x g prior to measurement with the Elecsys Vitamin D total II assay. If you are still experiencing issues after completing the steps above, discontinue the use of the Elecsys Vitamin D Total II assay. Contact the Roche Support Network Customer Support Center at 1-800-428-2336. For the MODULAR ANALYTICS E 170 module, cobas e 411 analyzer, and cobas e 601 and 602 analyzers, the availability of the Elecsys Vitamin D Assay (catalog number 06506780160) has been extended and may be used as an alternate method until this issue is resolved. Customers were asked to do the following: " Follow the workaround outlined in this Urgent Medical Device Correction (UMDC) to improve sample quality prior to measurement with the Elecsys Vitamin D total II assay until further information is provided. " If none of the workaround actions listed on the previous page successfully resolve the issue, please discontinue use of the Elecsys Vitamin D total II assay and contact the Roche Support Network Customer Support Center at 1-800-428-2336. " For all analyzers except the cobas e 801 module, the V
cobas e 801 immunoassay analyzer
The firm has confirmed complaints regarding signal drops on the cobas e 801 module after a ProCell II M bottle changeover, which may lead to incorrect medical decisions with respect to diagnostics and patient treatment.
On March 15, 2019, the firm notified affected customers of the recall via an Urgent Medical Device Correction letter. Customers were informed of the potential problem of signal drops when the standby bottle flowpath is covered with a biofilm. Customers were asked to do the following: " Follow the Workaround section to determine if your cobas e 801 module is potentially affected and perform the steps if applicable. " If your cobas e 801 module is potentially affected based on the information in the Workaround section of this UMDC, contact the Roche Support Network Customer Support Center at 1-800-428-2336 to schedule the ProCell II M flowpath decontamination procedure. The ProCell II M flowpath decontamination procedure should be performed every 4 weeks until your cobas e 801 module is switched to the improved ProCell II M formulation. " Identify and retest potentially affected patient samples using the Retrospectively Identify and Correct Potentially Affected Patient Sample Results section of this UMDC. " Complete the attached fax form and fax it to 1-833-254-2597 or email it to roche10068@stericycle.com.
Anti-HAV IgM test System, Material No. 11820591160 Product Usage: The Roche Elecsys Anti-HAV IgM immunoassay is used for the in vitro qualitative detection of IgM antibodies to hepatitis A virus (anti-HAV IgM) in human serum and plasma (potassium EDTA, lithium or sodium heparin, sodium citrate). The assay is intended for use as an aid in the laboratory diagnosis of an acute or recently acquired hepatitis A virus infection. Assay results, in conjunction with other laboratory results and clinical
Potential for erroneous result messages for the Anti-HAV IgM assay when run on the cobas e 602 module. Discrepant result reporting may result.
Roche issued URGENT MEDICAL DEVICE CORRECTION notices and Fax Forms dated 12/17/2018 to customers via UPS courier service. **Actions to be Taken by Customers/Users Currently Using APP-file Version 04.10 - 101** 1. If your LIS host stores the interpretation and COI information for Anti-HAV IgM, all COI results in the gray zone of 0.90 1.10 should be reviewed. Implement the following action for all gray zone results: If discrepant interpretation of results is suspected, re-testing may be advisable in concordance with the recommendations in the assay method sheet and relevant clinical information. 2. Review the APP-file version downloaded for the Anti-HAV IgM application. The most current APP-file version is (05.30 - 402). Download this version of the APP-file for the Anti-HAV IgM assay. You can determine the APP-file version for Anti-HAV IgM currently installed on your cobas e 602 module by going to Utility > Application > Select Anti-HAV IgM test > Analyze tab, bottom right corner of the screen. **Actions Required** - Follow the instructions provided in the Actions to be Taken by Customers/Users Currently Using APP-file Version 04.10 - 101 - Confirm your cobas e 602 module is using APP-file 05.30 - 402. If it is not, immediately update to APP-file 05.30 - 402. - Complete all sections of the fax form (TP-00518) and fax it to 1-855-207-2758 or email it to 6189roche@stericycle.com. - File the Urgent Medical Device Correction for future use. Customers with questions please contact the Roche Support Network Customer Support Center, 24 hours a day, seven days a week at 1-800-428-2336
Brand Name: cobas c 6000 MODULAR Series System e 601 cobas c 8000 MODULAR Series System - e 602 Roche / Hitachi MODULAR Analytics Combination System Model/Catalog/Part Number: MODULAR Analytics E 170 03022109001 03023109973 03739040001 03739040692 05023572001 05023599001 cobas e 601 module 04745922001 04745922692 05036348001 05036348692 05860652001 cobas e 602 module 05990378001 The Roche/Hitachi MODULAR Analytics System (E170) is a fully automated, random-access, software- c
Roche has confirmed that a possible sample mismatch issue may occur on the MODULAR ANALYTICS E 170 module, cobas e 601 analyzer, or cobas e 602 analyzer due to a software limitation.
Roche sent an Urgent Medical Device Correction (UMDC) sent via UPS Ground (receipt required) dated July 6, 2017, and an amended UMDC on August 31 ,2017. All consignees will be notified by Urgent Medical Device Correction sent via UPS Ground (receipt required). Customers/consignees were instructed the following: If the Tip/Cup pick up error alarm is issued then followed by the Abnormal L2-line Movement alarm on your MODULAR ANALYTICS E 170 module, cobas e 601 analyzer, or cobas e 602 analyzer, after which the system goes into Sampling Stop, follow the steps in this UMDC and the appropriate How to Identify Potentially Mismatched Sample Results within the enclosed document. For further questions, please call (317) 521-4343.
cobas e 801 immunoassay analyzer, cobas 8000 Modular Series The device is a fully automated, software controlled analyzer system for in vitro determination of analytes in human body fluids. It is part of the cobas 8000 modular analyzer series. It uses electrochemiluminescent technology for signal generation and measurement.
The syringe plunger on the device may be mounted in a tilted position, which applies mechanical stress to the plunger. In the worst case scenario, the plunger may crack leading to impaired syringe function.
On April 3, 2018, The Firm sent an Urgent Medical Device Correction letter via UPS Ground. Consignees were notified of the possible failure. Consignees were informed that a Roche representative would contact them to install a syringe plunger guide for the affected syringes to resolve the issue. In the meantime, consignees were instructed to only measure assays that do not require prewash steps and assays that are not impacted by missing prewash step until the syringe plunger guide is installed on the affected module. If the customer identifies broken syringe plungers on their device, the notice instructed them to contact the Roche Support Network Customer Support Center at 1-800-428-2336, available 24 hours a day, 7 days a week. Customers were asked to complete a customer response form and return it to the firm.
cobas b 221<2>Roche OMNI S2 system catalog numbers: 3337111001 and 3337111692 The Roche Diagnostics Omni S Analyzer is a fully automated critical care analyzer intended to be used for the measurement of pH, PCO2, PO2, sodium, potassium, ionized calcium, chloride, hematocrit, glucose, lactate, urea/BUN, total hemoglobin, oxygen saturation, oxyhemoglobin, deoxyhemoglobin, carboxyhemoglobin, and methemoglobin in samples of whole blood, serum, plasma, and aqueous solutions as appropriate.
The software responsible for starting scheduled AutoQC measurements (scheduler) will not activate.
ROCHE sent an Urgent Medical Device Correction Letter dated February 22, 2018, via UPS to affected customers. Customers were instructed to complete the following: " 1) Use the Return to Setup and Exit buttons to ensure execution of scheduled AutoQC measurements as described in this Urgent Medical Device Correction (UMDC); 2) Check to see if the next scheduled AutoQC measurement is performed to ensure the AutoQC scheduler is working as expected; 3) If your facility has distributed the affected product to another site, please ensure this UMDC is provided to that site; 4) Complete the attached fax form (TP-00146) and fax it to 1-844-491-7776 or scan and email to roche7570@stericycle.com; 5) File this UMDC for future reference. Customers with questions should contact the Roche Support Network Customer Support Center, 24 hours a day, seven days a week at 1-800-526-2272.
Roche cobas p 612 pre-analytical system (63x) Model: 07563116001 The cobas p 612 pre-analytical system is a computer controlled fully automatic system for sorting of open and closed barcoded and centrifuged and non-centrifuged sample tubes. The cobas p 612 is intended for use with analyzers that perform tests in the area of clinical chemistry, immuno chemistry, coagulation, hematology, urinalysis, nucleic acid testing.
Sample material may potentially come in contact with the pipetting nozzle during operation of cobas p 612 pre-analytical system (63x) (LCP1) with non-filter tips. The possible presence of biological material on the nozzle may cause contamination resulting in potential false positive results, depending on the sensitivity of the analytical technology.
The firm, Roche, issued an "URGENT MEDICAL DEVICE CORRECTION" letter dated 7/6/18 to its customers on 7/6/18. The letter described the product, problem and actions to be taken. The Customers were instructed to do the following: Complete all sections of the enclosed faxback form and fax it to number 1-866-469-2231 or email it to Roche6840@stericycle.com. " Ensure you have at least a two-week supply of disposable filter tips before the Roche FES arrives to modify your system. " Provide copies of this Urgent Medical Device Correction (UMDC) to other clinicians who may need to be aware of this issue. " If your facility has distributed the affected product to another site, please ensure this UMDC is provided to that site. " File this UMDC for future reference. If you are using cobas p 612 pre-analytical (63x) (LCP1) systems for aliquoting in combination with non-filter tips, you must use filter tips until the root cause is identified and appropriate corrective actions have been implemented. Please contact the Roche Support Network Customer Support Center, 24 hours a day, seven days a week at 1-800-428-2336 if you have questions about the information contained in this UMDC.
cobas e 411 Immunoassay Analyzer-Model/Catalog/Part number: 04775279001/04775279973 - cobas e 411 analyzer (disk system) and 04775201001/04775201973 - cobas e 411 analyzer (rack system), medial device listing number: E116019 cobas e 411 Elecsys analyzer is a fully automated, random access, computer controlled analytical systems for quantitative and qualitative determinations of analytes in body fluids.
A software malfunction can occur on the cobas e 411 and Elecsys 2010 analyzers in the Sample& Control data file which may lead to a potential data mismatch.
All consignees were notified by Urgent Medical Device Correction sent via UPS Ground (receipt required) on July 5, 2017. The customer is advised to perform the following actions: cobas e 411: Until the software update is available, use the workaround outlined in the Urgent Medical Device Correction (UMDC). Elecsys 2010: Use the workaround outlined in this Urgent Medical Device Correction (UMDC). Non-responding accounts will be defined as users for which confirmation of receipt of the Urgent Medical Device Correction (UMDC) cannot be obtained. These accounts will be monitored on an ongoing basis and follow-up attempts will be made accordingly. Workaround for customers: he customer is advised to perform the following actions: cobas e 411: Until the software update is available, use the workaround outlined in the Urgent Medical Device Correction (UMDC). Elecsys 2010: Use the workaround outlined in this Urgent Medical Device Correction (UMDC). For further questions, please call (317) 521-7259
Roche Acetaminophen assay 03255379160-HAcetaminophen (P) 20767174160- cobas c Integra AAcetaminophen150 test
The previous version of method sheets for the Acetaminophen assay on the COBAS INTEGRA 400 plus/800/800 CTS analyzers and the MODULAR ANALYTICS P module are missing the following statement in the Limitations-interference section: "In very rare cases, gammopathy, in particular type IgM (Waldenstrm s macroglobulinemia), may cause unreliable results."
On January 2, 2018 an URGENT MEDICAL DEVICE CORRECTION letter was issued to customers with notification to the issue and information regarding the updated method sheets and that they were available for use. The COBAS INTEGRA 400 plus/800/800 CTS was updated from affected method sheet version 3.0 to 4.0. The MODULAR ANALYTICS P was updated from affected method sheet version 4.0 to 5.0 No product return is required. Please contact the Roche Support Network Customer Support Center, 24 hours a day, seven days a week at 1-800-428-2336 if you have questions about the information contained in this UMDC.
c6000, Chemistry (Photometric, Discrete), for clinical use. - cobas e 601 module: Immunoassay Analyzer, Catalog Numbers: 04745922001, 05036348001, 05860652001, 04745922692, 05036348001 & 05036348692
Complaints have been received concerning questionable results on analyzers due to customers utilizing 13 sample tubes without tube adapters.
Roche Diagnostics Corporation issued Urgent Medical Device Correction (UMDC) notices and Fax Forms to their customers dated 12/18/2017 via UPS Ground (receipt required). Customers are encouraged to do the following Mandatory Steps to improve the vertical alignment and handling of 13 mm sample tubes and false bottom tubes: FOR cobas e 411 & cobas e 601 analyzers and MODULAR ANALYTICS E 170 module: 1) Always use Roche rack cup adapters with 13 mm tubes 2) Ensure sample tubes are straight FOR cobas e 411 disk system: 1) Always use 13 mm Sample Disk Tube Adapters (SDTAs) with 13 mm sample tubes. 2) Ensure sample tubes are straight. 3) Ensure 13 mm SDTAs are not exposed to direct sunlight. 4) If a larger diameter tube is left inserted in a 13 mm SDTA for more than 3 days, the adapter may become distorted. Do not insert smaller diameter tubes into distorted adapter as they may not align correctly. **All customers are encouraged to DISCARD Analyzer Bulletin 10-009U3. Follow the care and handling instructions for using adapters as outlined in this Urgent Medical Device Correction (UMDC) and complete & return the UMDC fax form via fax to 1-877-271-1472
Elecsys BRAHMS PCT Immunoassay for the in vitro quantitative determination of PCT (procalcitonin) in human serum and plasma (K2 and K3 EDTA, Li-Heparin).
Product exhibits a decreased recovery of patient samples on the cobas e 801 module compared to the MODULAR ANALYTICS E 170, cobas e 411, 601, and 602 analyzers.
The firm, Roche, sent an "URGENT MEDICAL DEVICE REMOVAL" letter dated December 22, 2017 to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to do the following: " Immediately discontinue use of Elecsys BRAHMS PCT (catalog number 07301715190) reagent lot number 204084 on the cobas e 801 module. " Discard affected product according to local guidelines. " Complete the attached fax form and fax it to 1-800-722-7222. " File this Urgent Medical Device Removal (UMDR) for future reference. Please contact the Roche Support Network Customer Support Center, 24 hours a day, seven days a week at 1-800-428-2336 if you have questions about the information contained in this UMDR.