BEUDAMED
    FDA Recall Terminated

    Pacific Hemostasis FDP Latex Reagent, REF/Model Number 100651, UDI 00845275000870, 1 x 5 mL, IVD; --- Fisher Diagnostics, a division of Fisher Scientific Company, LLC, a part of Thermo Fisher Scientific Inc., Middletown, VA 22645-1905 USA

    Recall: Z-2763-2017 · Initiated May 19, 2017

    Recall

    Recall Number
    Z-2763-2017
    Event Number
    77340
    Firm
    Fisher Diagnostics
    FEI Number
    1181121
    Product Code
    KQJ
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    May 19, 2017
    Terminated
    June 29, 2018
    Address
    8365 Valley Pike, Middletown, VA, 22645-1905

    Description

    Pacific Hemostasis FDP Latex Reagent, REF/Model Number 100651, UDI 00845275000870, 1 x 5 mL, IVD; --- Fisher Diagnostics, a division of Fisher Scientific Company, LLC, a part of Thermo Fisher Scientific Inc., Middletown, VA 22645-1905 USA

    Reason

    An issue was discovered with the Pacific Hemostasis Fibrinogen Degradation Products (FDP) kit, list number 100650, lot 948546 and FDP Latex Reagent, list 100651, lot 890199. While the kit performs accurately at FDP concentrations greater than 20 g/ml, there is an observed reduction in sensitivity when FDP levels are less than 20 g/ml. This reduction in sensitivity has been tied to FDP Latex Reagent lot 890199 and may result in false negatives.

    Action

    ThermoFisher Scientific sent an MEDICAL DEVICE RECALL Letter dated May 16, 2017, to all affected customers and response forms were sent to customers on May 19, 2017. Customers are informed of the recall and potential health risks and instructed to review their test results. Review your inventory and any product on hand is to be discarded. --- The firm ceased distribution of the lots and began its investigation. The held product will ultimately be destroyed. Level A effectiveness checks will be conducted to the consignees and repeated attempts will be made to non-responding customers. The firm will track all mailed, emailed and faxed return forms for the duration of the recall. For further questions, please call (540) 869-8188.

    Distribution

    USA (nationwide) including Puerto Rico, and Internationally to Colombia

    Quantity

    27 units