BEUDAMED
    FDA Enforcement Class II Terminated

    Nucleic Acid test intended for screening for MRSA/SA. Each kit has 20 tubes. in vitro diagnostic.

    Recall: Z-1195-2018 · Reported April 4, 2018

    Enforcement

    Recall Number
    Z-1195-2018
    Event ID
    79375
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Roche Molecular Systems, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 4, 2018
    Initiation Date
    October 27, 2017
    Classification Date
    March 26, 2018
    Termination Date
    April 27, 2020
    Address
    1080 US Highway 202 S, Branchburg, NJ, 08876-3733, United States

    Description

    Nucleic Acid test intended for screening for MRSA/SA. Each kit has 20 tubes. in vitro diagnostic.

    Reason

    The cobas MRSA/SA tests may have decreased performance compared to the analytical sensitivity for MSRA detection. A screening failure can lead to potential infection in the colonized patient being tested as well as the spread of MSRA to others. The United States is not impacted, as the cobas MRSA/SA nucleic acid test for use on the cobas liat system is not available in the US.

    Code Info

    Lot #s: 70712A (6 kits); 70601W (76 kits); 70713A (4 kits); 70718A (50 kits); and 70809A (kits were not distributed to end users).

    Distribution

    Worldwide distribution. Austria, Denmark, Germany, Singapore, Netherlands, Hong Kong, and Switzerland. US product is not affected.

    Quantity

    136 kits