BEUDAMED
    FDA Enforcement Class II Terminated

    Roche Elecsys Anti-CCP Immunoassay Catalog # 05031656160

    Recall: Z-2362-2019 · Reported September 4, 2019

    Enforcement

    Recall Number
    Z-2362-2019
    Event ID
    83416
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Roche Diagnostics Operations, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 4, 2019
    Initiation Date
    July 16, 2019
    Classification Date
    August 23, 2019
    Termination Date
    April 30, 2021
    Address
    9115 Hague Rd, N/A, Indianapolis, IN, 46256-1025, United States

    Description

    Roche Elecsys Anti-CCP Immunoassay Catalog # 05031656160

    Reason

    Performance issues with certain lots of the Elecsys Anti-CCP assay on the cobas e 411 analyzer; MODULAR ANALYTICS E 170 module; and cobas e 601, 602, and 801 modules with plasma samples.

    Code Info

    Lot # 376808 Exp 08/31/2019 Lot # 389165 Exp 09/30/2019 Anti-CCP assay: Anti-CCP Elecsys cobas e 100 The affected lots of Anti-CCP have been distributed 02/28/2019 through 07/01/2019. ***Updated 7/17/20*** Current (in-date) and future lots of both Catalog numbers are impacted. In-date lots: 443981, exp. 07/31/2020 457164, exp. 09/30/2020

    Distribution

    AZ CA FL HI IA IL IN KY LA MA MI MO MT NJ NY OK OR PA PR SC TX VA

    Quantity

    550