BEUDAMED
    FDA Enforcement Class II Terminated

    SimpliRED D-Dimer, Product Code DSRK4 The SimpliRED D-dimer assay is a rapid, qualitative test for the detection of cross-linked fibrin degradation products containing the cross-linked D-diner site in human whole blood

    Recall: Z-0314-2017 · Reported November 2, 2016

    Enforcement

    Recall Number
    Z-0314-2017
    Event ID
    74786
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    BBI SOLUTIONS OEM LTD
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    November 2, 2016
    Initiation Date
    June 1, 2016
    Classification Date
    October 27, 2016
    Termination Date
    June 14, 2018
    Address
    8 Tom McDonald Avenue, Dundee, N/A, United Kingdom

    Description

    SimpliRED D-Dimer, Product Code DSRK4 The SimpliRED D-dimer assay is a rapid, qualitative test for the detection of cross-linked fibrin degradation products containing the cross-linked D-diner site in human whole blood

    Reason

    A component of the kit is showing a sensitivity performance detected in stability testing at 15 months of an 18-month shelf life. Qualitative results may be affected. False negative results are possible which may incorrectly influence the clinical diagnostic decision.

    Code Info

    Lot Numbers containing test reagent lot # 1012-34437): BU183A, BU183B, BU184A, BU185A, BU185B Expiration Date: 31 JUL 2016

    Distribution

    US distribution to CT and IN

    Quantity

    420 units (183 units quarantined)