BEUDAMED
    FDA Enforcement Class II Terminated

    Remel Blood Agar/MacConkey Agar Bi-Plate, REF: R02049

    Recall: Z-0769-2021 · Reported January 20, 2021

    Enforcement

    Recall Number
    Z-0769-2021
    Event ID
    87010
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Remel Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    January 20, 2021
    Initiation Date
    December 10, 2020
    Classification Date
    January 14, 2021
    Termination Date
    July 6, 2023
    Address
    12076 Santa Fe Trail Dr, N/A, Lenexa, KS, 66215-3519, United States

    Description

    Remel Blood Agar/MacConkey Agar Bi-Plate, REF: R02049

    Reason

    The blood agar side of the bi-plate may not grow some patient isolates or QC organisms as intended.

    Code Info

    Lot 150237

    Distribution

    Distribution in United States - AL, FL, GA, LA MS, NC, SC, TN

    Quantity

    637 units