BEUDAMED
    FDA Recall Terminated

    Tina-quant C-Reactive Protein Gen.3, Catalog number 05172373190 - Product Usage: the in vitro quantitative determination of CRP in human serum and plasma on Roche automated clinical chemistry analyzers.

    Recall: Z-0634-2021 · Initiated November 6, 2020

    Recall

    Recall Number
    Z-0634-2021
    Event Number
    86745
    Firm
    Roche Diagnostics Operations, Inc.
    FEI Number
    1823260
    Product Code
    DCN
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    November 6, 2020
    Terminated
    October 18, 2024
    Address
    9115 Hague Rd, Indianapolis, IN, 46256-1025

    Description

    Tina-quant C-Reactive Protein Gen.3, Catalog number 05172373190 - Product Usage: the in vitro quantitative determination of CRP in human serum and plasma on Roche automated clinical chemistry analyzers.

    Reason

    Roche confirmed customer complaints of low quality (QC) recovery and invalid calibrations for the Tina-quant C-Reactive Protein Gen. 3 on the cobas c701 and 702 modules. A discoloration (yellow color) was observed and is the result of cross contamination between the R1 and R3 reagents.

    Action

    On November 6, 2020, the firm mailed customers Urgent Medical Device Correction letters. Customers were informed that the present communication serves as an update to previous UMDCs sent on 9/11/2019, 12/18/2019, and 8/27/2020, in that it includes the new product and lot number listed above. Customer Instructions: " Discontinue use and discard any remaining affected product in your inventory according to your local waste guidelines. " Refer to the Product Replacement section on page 2 of the UMDC for product replacement information. " Complete all sections of the enclosed faxback form (TP-01128) and fax or email it according to the instructions on the form even if you are not requesting product replacement. " 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. 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 this recall.

    Distribution

    US Nationwide distribution including in the states of AL, CA, FL, GA, HI, IA, IL, IN, KY, MA, MD, MI, MN, MO, NJ, NY, OH, PA, SC, TN, TX, VA.

    Quantity

    699 units