BEUDAMED
    FDA Recall Terminated

    Roche Elecsys total PSA CalSet, catalog number 11731696322.

    Recall: Z-0382-06 · Initiated December 7, 2005

    Recall

    Recall Number
    Z-0382-06
    Event Number
    34273
    Firm
    Roche Diagnostics Corp.
    FEI Number
    1823260
    Product Code
    LTJ
    Status
    Terminated
    Root Cause
    Other
    Initiated
    December 7, 2005
    Posted
    January 11, 2006
    Terminated
    February 26, 2006
    Address
    9115 Hague Rd, Indianapolis, IN, 46256-1025

    Description

    Roche Elecsys total PSA CalSet, catalog number 11731696322.

    Reason

    There is the possibility of high results with sera expected to have non-detectable levels of tPSA if these reagent lots are used in combination on the Modular Analytics E170 analyzer.

    Action

    Consignees were notified of the incompatibility via reagent bulletin dated 12/7/05.

    Distribution

    Nationwide.

    Quantity

    25,000 kits