BEUDAMED
    FDA Enforcement Class II Terminated

    cobas SARS-CoV-2 & Influenza A/B Test for use on the cobas Liat System, Catalog Number 09211101190

    Recall: Z-2498-2021 · Reported September 29, 2021

    Enforcement

    Recall Number
    Z-2498-2021
    Event ID
    88600
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Roche Molecular Systems, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Report Date
    September 29, 2021
    Initiation Date
    August 4, 2021
    Classification Date
    September 21, 2021
    Termination Date
    February 23, 2024
    Address
    1080 US Highway 202 S, Branchburg, NJ, 08876-3733, United States

    Description

    cobas SARS-CoV-2 & Influenza A/B Test for use on the cobas Liat System, Catalog Number 09211101190

    Reason

    Customers have reported an increased number of false positive SARS-CoV-2 results.

    Code Info

    Lot 10119Z

    Distribution

    Worldwide distribution - US Nationwide distribution in the states of AR, CA, IL, IN, KS, ME, MI, MN, MO, NY, OR, TN, TX, WA, and WI. The countries of Canada, UK, Austria, Belgium, Croatia, Denmark, Finland, France, Germany, Netherlands, Norway, Poland, Slovakia, and Spain.

    Quantity

    211 kits (US); 3073 kits (OUS)