BEUDAMED
    FDA Recall Terminated

    Pacific Hemostasis D-Dimer Assay Kit, Fisher Diagnostics Catalog Number 100660, packaged in a cardboard box containing materials and reagents to perform 80 tests.

    Recall: Z-1336-04 · Initiated July 1, 2004

    Recall

    Recall Number
    Z-1336-04
    Event Number
    29573
    Firm
    Fisher Diagnostic, A Company of Fisher Scientific LLC
    FEI Number
    1181121
    Product Code
    GHH
    Status
    Terminated
    Root Cause
    Other
    Initiated
    July 1, 2004
    Posted
    August 11, 2004
    Terminated
    December 7, 2004
    Address
    8365 Valley Pike, Middletown, VA, 22645-1905

    Description

    Pacific Hemostasis D-Dimer Assay Kit, Fisher Diagnostics Catalog Number 100660, packaged in a cardboard box containing materials and reagents to perform 80 tests.

    Reason

    Defective reagent may cause in vitro diagnostic test kit to yield false positive test results in clinical samples.

    Action

    The recalling firm notified consignees on 7/1/04 by letter flagged as a customer notification. The notice describes the potential for invalid control results using the speckled cards. The letter requests users to return the cards for replacement. Defective cards are described as isolated to those packaged in heat sealed cellophane type bags. The firm requests customers to return a response form with quantity needed for replacement.

    Distribution

    Product was sold primarily to clinical laboratories nationwide and to international distributors

    Quantity

    5677 kits