BEUDAMED
    FDA Recall Open, Classified

    Cepheid Xpert MRSA/MRSA NxG Control Panel (Catalog #8195) UDI: 70845357041226 Product Usage: On April 9, 2019, Microbiologics sent ACTION REQUIRED: MEDICAL DEVICE CORRECTION emails to their direct US consignees requesting them to complete a MEDICAL DEVICE CORRECTION FORM indicating how much product they had on hand.

    Recall: Z-1730-2019 · Initiated April 9, 2019

    Recall

    Recall Number
    Z-1730-2019
    Event Number
    82783
    Firm
    Microbiologics Inc
    FEI Number
    2150138
    Product Code
    PMN
    Status
    Open, Classified
    Root Cause
    Incorrect or no expiration date
    Initiated
    April 9, 2019
    Address
    200 Cooper Ave N, Saint Cloud, MN, 56303-4440

    Description

    Cepheid Xpert MRSA/MRSA NxG Control Panel (Catalog #8195) UDI: 70845357041226 Product Usage: On April 9, 2019, Microbiologics sent ACTION REQUIRED: MEDICAL DEVICE CORRECTION emails to their direct US consignees requesting them to complete a MEDICAL DEVICE CORRECTION FORM indicating how much product they had on hand.

    Reason

    Product with incorrect shelf life.

    Action

    On April 9, 2019, Microbiologics sent ACTION REQUIRED: MEDICAL DEVICE CORRECTION emails to their direct US consignees requesting them to complete a MEDICAL DEVICE CORRECTION FORM indicating how much product they had on hand.

    Distribution

    Worldwide Distribution - US Nationwide AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, KY, MA, MD, MI, MO,MS, MT, NC, ND, NJ, NY, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WV, and WY. Australia, Chile, Germany, New Zealand, and United Kingdom.

    Quantity

    249