BEUDAMED
    FDA Enforcement Class II Ongoing

    Thermo Scientific Sensititre Gram Negative Susceptibility Testing Plate, IVD format

    Recall: Z-0722-2022 · Reported March 16, 2022

    Enforcement

    Recall Number
    Z-0722-2022
    Event ID
    89416
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Remel Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 16, 2022
    Initiation Date
    January 10, 2022
    Classification Date
    March 4, 2022
    Address
    12076 Santa Fe Trail Dr, N/A, Lenexa, KS, 66215-3519, United States

    Description

    Thermo Scientific Sensititre Gram Negative Susceptibility Testing Plate, IVD format

    Reason

    There are lower than expected MICs for some gram negative species.

    Code Info

    Product Number MDRGN2F; Lots: 1) B1402A (Expiration 2022/Oct05) 2) B1315A (Expiration 2022/Aug06) 3) B1211 (Expiration 2022/May24) 4) B1161A (Expiration 2022/Apr19 5) B0361 (Expiration 2021/Aug31) 6) B0164B (Expiration 2021/Apr16)

    Distribution

    Distribution throughout the United States.

    Quantity

    1210 devices