BEUDAMED
    FDA Recall Terminated

    Elecsys CA 19-9, Cat. No. 07027028190 - Product Usage: the product is an immunoassay for monitoring and management of pancreatic cancer

    Recall: Z-1444-2020 · Initiated February 7, 2020

    Recall

    Recall Number
    Z-1444-2020
    Event Number
    84915
    Firm
    Roche Diagnostics Operations, Inc.
    FEI Number
    1823260
    Product Code
    NIG
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    February 7, 2020
    Posted
    March 5, 2020
    Terminated
    May 30, 2024
    Address
    9115 Hague Rd, Indianapolis, IN, 46256-1025

    Description

    Elecsys CA 19-9, Cat. No. 07027028190 - Product Usage: the product is an immunoassay for monitoring and management of pancreatic cancer

    Reason

    The firm has received an increased number of complaints concerning non-reproducible elevated results ("high flyers") for one lot of Elecsys CA 19-9 reagent, which may affect clinical interpretation.

    Action

    On February 7, 2020, the firm issued an Urgent Medical Device Correction letter to affected customers. Customers were informed of the product issue and given two options for CA 19-9 testing until another reagent lot is available for the cobas e 801 module: 1) Use a different Roche platform for testing, or 2) Implement a workaround, described in detail in the customer letter. The letter also provided instructions for receiving credit depending on which option was elected. Roche will notify customers when a new lot of CA 19-9 reagent for the cobas e 801 is available for ordering. ***Updated 10/5/20*** On 10/2/20, the firm issued an updated letter to customers to communicate an expansion to the recall. An additional lot was added to the recall scope.

    Distribution

    US Nationwide distribution in the states of AL, AZ, CA, CO, FL, HI, IL, IN, KS, KY, MA, ME, MI, NC, NH, NJ, NY, TN, TX, WA and WI.

    Quantity

    684