BEUDAMED
    FDA Recall Terminated

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

    Recall: Z-0769-2021 · Initiated December 10, 2020

    Recall

    Recall Number
    Z-0769-2021
    Event Number
    87010
    Firm
    Remel Inc
    FEI Number
    1924669
    Product Code
    JSI
    Status
    Terminated
    Root Cause
    Mixed-up of materials/components
    Initiated
    December 10, 2020
    Terminated
    July 6, 2023
    Address
    12076 Santa Fe Trail Dr, Lenexa, KS, 66215-3519

    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.

    Action

    The recalling firm issued a recall notification letter dated 12/16/2020 to all impacted customers. The letter states that all impacted product has since expired on 12/10/2020. Customers are asked to review of reported test results should be determined by the appropriate technical expert. Customers are also asked to keep the notification letter on file. The notice should be passed on to all who need to be aware within the organization or to any organization where the potentially affected products have been transferred. Questions may be directed to the Technical Services Department at 1-800-255-6730 (US) or via email: [email protected].

    Distribution

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

    Quantity

    637 units