BEUDAMED
    FDA Recall Terminated

    remel THIOGLYCOLLATE MEDIUM, REF 05152

    Recall: Z-3019-2018 · Initiated August 13, 2018

    Recall

    Recall Number
    Z-3019-2018
    Event Number
    80813
    Firm
    Remel Inc
    FEI Number
    1924669
    Product Code
    JSG
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    August 13, 2018
    Terminated
    June 18, 2019
    Address
    12076 Santa Fe Trail Dr, Lenexa, KS, 66215-3519

    Description

    remel THIOGLYCOLLATE MEDIUM, REF 05152

    Reason

    Products have intermittently failed performance testing during stability studies with various anaerobic microorganisms.

    Action

    The firm initiated the recall by letter on 08/13/2018. The firm directed the consignee to you inspect their stock and destroy any remaining inventory of the lots listed above and contact Customer Services or your local distributor regarding replacement. They also requested that the consignee review results and laboratory reporting associated with use of the listed lots and consider retesting and/or seek appropriate expert advice for further action. The firm instructed the consignee to further distribute the notice to all who need to be aware within your organization or to any organization where the potentially affected products have been transferred. For questions, please contact Technical Services Department at 800-255-6730 (US) or 913-888-0939 (International).

    Distribution

    US, Canada, Singapore

    Quantity

    48 units