BEUDAMED
    FDA Recall Terminated

    Stratus CS STAT Fluorometric Analyzer BHCG TestPak (CBHCG) in vitro diagnostic.

    Recall: Z-0874-06 · Initiated April 3, 2006

    Recall

    Recall Number
    Z-0874-06
    Event Number
    35112
    Firm
    Dade Behring Inc.
    FEI Number
    2517506
    Product Code
    DHA
    Status
    Terminated
    Root Cause
    Other
    Initiated
    April 3, 2006
    Posted
    May 19, 2006
    Terminated
    August 7, 2006
    Address
    500 GBC Dr. PO BOX 6101, Mailstop 514, Newark, DE, 19714-6101

    Description

    Stratus CS STAT Fluorometric Analyzer BHCG TestPak (CBHCG) in vitro diagnostic.

    Reason

    Foil sealing of theTestPak may occlude the pipet tip resulting in insufficient aspiration of fluids. Erroneous test results may be generated without an associated error code. Test results may be falsely elevated or depressed, and the magnitude of the inaccuracy may vary based on the degree of occlusion.

    Action

    Customers were provided clear written instructions (04/06/2006) to discontinue use and discard remaining inventory of products over 2 months old. In addition, each customer is being contacted by phone as an effectiveness verification. Recalling firm is also instructing Stratus CS customers to process all samples and dilutions in duplicate.

    Distribution

    Nationwide to hospitals and government accounts in addition to International accounts in Canada, Saudi Arabia, Bangladesh, UAE, India, Japan, Denmark, and Australia.

    Quantity

    126 cartons of 100 TestPaks