Class 2 Device Recall Roche Diagnostics Tinaquant IgM Gen.2

• Date Initiated by Firm: December 17, 2018
• Date Posted: April 13, 2019
• Recall Status: Terminated on November 02, 2020
• Recall Number: Z-1147-2019
• Recall Event ID: 81859
• 510(K)Number: K040431
• Product Classification: Igg (fd fragment specific), antigen, antiserum, control - Product Code DAQ
• Product: Tina-quant IgM Gen.2, Catalog Nos. 03507190190, 05220726190, 03507041190, 03507149190; ; Product Usage:; Immunoturbidimetric assay for the quantitative in vitro determination of IgM in human serum and plasma on automated clinical chemistry analyzers analyzers.
• Code Information: n/a
• Recalling Firm/ Manufacturer: Roche Diagnostics Corporation; 9115 Hague Rd; Indianapolis IN 46256-1025
• For Additional Information Contact: Roche Support Network Customer Support Center; 800-428-2336
• Manufacturer Reason for Recall: 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***
• FDA Determined Cause: Device Design
• Action: 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
• Quantity in Commerce: 5292 analytical units
• Distribution: US Nationwide distribution.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = DAQ and Original Applicant = ROCHE DIAGNOSTICS CORP.