BEUDAMED
    FDA Recall Terminated

    Chlamydia OIA. For in vitro diagnostic use.

    Recall: Z-0616-03 · Initiated February 7, 2003

    Recall

    Recall Number
    Z-0616-03
    Event Number
    25589
    Firm
    Thermo Biostar, Incorporated
    FEI Number
    1720655
    Product Code
    LJC
    Status
    Terminated
    Root Cause
    Other
    Initiated
    February 7, 2003
    Posted
    March 6, 2003
    Terminated
    May 2, 2003
    Address
    331 South 104th Street, Louisville, CO, 80027

    Description

    Chlamydia OIA. For in vitro diagnostic use.

    Reason

    Chlamydia IVD test kits may contain diluted conjugate reagent. Use may produce a false negative result with a low positive patient sample.

    Action

    All consignees were notified by telephone on 2/6/2003, followed by letter on 2/10/2003.

    Distribution

    Nationwide, and to France, New Zealand and Spain.

    Quantity

    56 units