BEUDAMED
    FDA Recall Open, Classified

    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 · Initiated May 23, 2018

    Recall

    Recall Number
    Z-0537-2020
    Event Number
    83930
    Firm
    Helena Laboratories, Corp.
    FEI Number
    1618982
    Product Code
    GHR
    Status
    Open, Classified
    Root Cause
    Unknown/Undetermined by firm
    Initiated
    May 23, 2018
    Address
    1530 Lindbergh Dr, Beaumont, TX, 77707-4131

    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.

    Action

    On 05/23/2018, the firm's technical services contacted consignees via phone call with a email follow-up of their recall notification letter. Consignees were advised of the following: 1. Prevent any shipment or schedule demonstrations with these lots 2. Remove the lots from available inventory and discard COLLAGEN vials. 3. Verify amount REMOVED FROM STOCK 4. COMPLETE THE FORM AND RETURN TO HELENA LABORATORIES, USA VIA: fax: 409-842-1874 OR E-MAIL TO [email protected]. For questions, contact Jessica W. Jones, MD, MPH - Mgr., Technical Services at: 1 (409) 842-3714 ext. 1177

    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