BEUDAMED
    FDA Recall Terminated

    Blastomyces dermatitidis Antiserum 1 mL vial GIBSON BIOSCIENCE. Catalog 200265 Intended for identification of the systemic fungal pathogens.

    Recall: Z-0606-2018 · Initiated January 20, 2017

    Recall

    Recall Number
    Z-0606-2018
    Event Number
    78731
    Firm
    Gibson Laboratories LLC
    FEI Number
    1050138
    Product Code
    LSI
    Status
    Terminated
    Root Cause
    Mixed-up of materials/components
    Initiated
    January 20, 2017
    Terminated
    February 20, 2018
    Address
    1040 Manchester St, Lexington, KY, 40508-2422

    Description

    Blastomyces dermatitidis Antiserum 1 mL vial GIBSON BIOSCIENCE. Catalog 200265 Intended for identification of the systemic fungal pathogens.

    Reason

    The firm information that the product was reporting false positive results

    Action

    On January 20, 2017, the firm sent Urgent Medical Device Recall notification letter and response form to their customers. The letter identified the affected and the reason for the recall. Users are instructed not to use any Blastomyces dermatitidis (catalog # 200265) that they may have in inventory and to quarantine any affected product. Return any affected product per the instructions provided; and, complete and return the attached acknowledgement form. Questions regarding this recall should be directed to Penny Epperson, Quality Manager, at 859-303-5169 or [email protected].

    Distribution

    Distributed to the states of AL, AZ & MS.

    Quantity

    10/1 mL vials