BEUDAMED
    FDA Recall Terminated

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

    Recall: Z-1195-2018 · Initiated October 27, 2017

    Recall

    Recall Number
    Z-1195-2018
    Event Number
    79375
    Firm
    Roche Molecular Systems, Inc.
    FEI Number
    2243471
    Product Code
    NQX
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    October 27, 2017
    Terminated
    April 27, 2020
    Address
    1080 US Highway 202 S, Branchburg, NJ, 08876-3733

    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.

    Action

    The cobas MRSA/SA tests has the potential for 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.

    Distribution

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

    Quantity

    136 kits