BEUDAMED
    FDA Enforcement Class III Ongoing

    Collagen Reagent, Cat. No. 5368, 2 X 1 mL, For use in platelet aggregation studies, Contains: Collagen (equine tendon) For In-Vitro Diagnostic Use,

    Recall: Z-0537-2020 · Reported December 4, 2019

    Enforcement

    Recall Number
    Z-0537-2020
    Event ID
    83930
    Classification
    Class III
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Helena Laboratories, Corp.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    December 4, 2019
    Initiation Date
    May 23, 2018
    Classification Date
    November 22, 2019
    Address
    1530 Lindbergh Dr, Beaumont, TX, 77707-4131, United States

    Description

    Collagen Reagent, Cat. No. 5368, 2 X 1 mL, For use in platelet aggregation studies, Contains: Collagen (equine tendon) For In-Vitro Diagnostic Use,

    Reason

    Through an investigation, it has been determined that vials of Collagen packaged within the Collagen Reagent and Platelet aggregation Kit, may contain particulate matter or microbial growth.

    Code Info

    Component Lot # 5-17-5368 (Collagen), Exp. 5/31/19 Kit Lot # 3-17-5369

    Distribution

    US:TX, WV, OH, TN, GA, TN, NY, ME, MA,LA, AZ OUS: Israel, Korea, Australia, Indonesia, Canada, Thailand, Colombia, Brasil , China , Taiwan

    Quantity

    64 Aggregation Kits