BEUDAMED
    FDA Recall Terminated

    Roche Tina-Quant ASLO (Anti-streptolysin O) Reagent Kit; Catalog No. 1931601 (Roche Material No. 11931601216) Lot No. 674653

    Recall: Z-1385-06 · Initiated July 25, 2006

    Recall

    Recall Number
    Z-1385-06
    Event Number
    35791
    Firm
    Roche Diagnostics Corp.
    FEI Number
    1823260
    Product Code
    GTQ
    Status
    Terminated
    Root Cause
    Other
    Initiated
    July 25, 2006
    Posted
    August 9, 2006
    Terminated
    April 18, 2007
    Address
    9115 Hague Rd, Indianapolis, IN, 46256-1025

    Description

    Roche Tina-Quant ASLO (Anti-streptolysin O) Reagent Kit; Catalog No. 1931601 (Roche Material No. 11931601216) Lot No. 674653

    Reason

    The vial containing the R2 reagent is labeled as R1 reagent and if placed in the R1 slot of the analyzer, erroneous results will be obtained. (extremely low patient and control results)

    Action

    Consignees were notified via recall letter dated 7/25/06 to cease using and to discard the product.

    Distribution

    Nationwide including the states of Arizona, California, New Jersey and Pennsylvania.

    Quantity

    20 kits.