BEUDAMED
    FDA Recall Terminated

    Thyrotest TSH POC Rapid membrane test. In vitro diagnostic.

    Recall: Z-0646-2007 · Initiated January 24, 2007

    Recall

    Recall Number
    Z-0646-2007
    Event Number
    37473
    Firm
    ThyroTec Inc
    FEI Number
    3004844724
    Product Code
    JLW
    Status
    Terminated
    Root Cause
    Other
    Initiated
    January 24, 2007
    Posted
    March 22, 2007
    Terminated
    June 4, 2007
    Address
    1801 Horseshoe Pike, Ste 1, Honey Brook, PA, 19344-8500

    Description

    Thyrotest TSH POC Rapid membrane test. In vitro diagnostic.

    Reason

    Positive control showed little or no positive line.

    Action

    On 1/24/07 the recalling firm notified their only customer of the problem. On 2/5/07, the distributor issued recall letters to their customers informing of the problem and the need to destroy the kits. The kits from lot number 02106-06 were returned to the recalling firm.

    Distribution

    Nationwide.

    Quantity

    484 units