BEUDAMED
    FDA Enforcement Class II Terminated

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

    Recall: Z-0606-2018 · Reported February 21, 2018

    Enforcement

    Recall Number
    Z-0606-2018
    Event ID
    78731
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Gibson Laboratories LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 21, 2018
    Initiation Date
    January 20, 2017
    Classification Date
    February 13, 2018
    Termination Date
    February 20, 2018
    Address
    1040 Manchester St, Lexington, KY, 40508-2422, United States

    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

    Code Info

    Lot # 5072543 Exp Date 03/12/2021; UDI : 10634853000039.

    Distribution

    Distributed to the states of AL, AZ & MS.

    Quantity

    10/1 mL vials