BEUDAMED
    FDA Enforcement Class II Terminated

    Pacific Hemostasis FDP (Fibrinogen Degradation Products) Assay Kit (30 Determinations), REF/Model 100650, UDI 00845275000863, IVD; --- Fisher Diagnostics, a division of Fisher Scientific Company LLC ,a part of Thermo Fisher Scientific Inc., Middletown, VA 22645-1905 USA --- For determination of Fibrinogen Degradation products in serum and urine.

    Recall: Z-2762-2017 · Reported August 2, 2017

    Enforcement

    Recall Number
    Z-2762-2017
    Event ID
    77340
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Fisher Diagnostics
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 2, 2017
    Initiation Date
    May 19, 2017
    Classification Date
    July 25, 2017
    Termination Date
    June 29, 2018
    Address
    8365 Valley Pike, N/A, Middletown, VA, 22645-1905, United States

    Description

    Pacific Hemostasis FDP (Fibrinogen Degradation Products) Assay Kit (30 Determinations), REF/Model 100650, UDI 00845275000863, IVD; --- Fisher Diagnostics, a division of Fisher Scientific Company LLC ,a part of Thermo Fisher Scientific Inc., Middletown, VA 22645-1905 USA --- For determination of Fibrinogen Degradation products in serum and urine.

    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.

    Code Info

    Lot Number 948546, Exp. 9/30/2017

    Distribution

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

    Quantity

    331 units