BEUDAMED
    FDA Recall 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 · Initiated June 1, 2016

    Recall

    Recall Number
    Z-0314-2017
    Event Number
    74786
    Firm
    BBI SOLUTIONS OEM LTD 8 Tom McDonald Avenue Dundee United Kingdom
    FEI Number
    3012801636
    Product Code
    GHH
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    June 1, 2016
    Terminated
    June 14, 2018

    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.

    Action

    BBI Solutions sent an Urgent Medical Device Recall letter dated June 30, 2016, to all affected customers. Customers were advised to immediately discontinue use of the product, consider the requirement for review of reported test results, complete and return the customer acknowledgement form to BBI Solutions and to complete and return the customer reconciliation form to the distributor. Customers who have forwarded product to other sites, should inform those customers of the product recall and provide them with a copy of the notice. Customers with questions were instructed to call Tel: +44(0)1382 564093.

    Distribution

    US distribution to CT and IN

    Quantity

    420 units (183 units quarantined)