BEUDAMED
    FDA Recall Terminated

    Roche PTH (parathyroid hormone test system) for use in conjunction with Roche cobas e 411, cobas e 601, Elecsys 1010, Elecsys 2010 and Modular E 170 analyzers; catalog no. 11972103122.

    Recall: Z-0810-2007 · Initiated April 19, 2007

    Recall

    Recall Number
    Z-0810-2007
    Event Number
    37761
    Firm
    Roche Diagnostics Corp.
    FEI Number
    1823260
    Product Code
    CEW
    Status
    Terminated
    Root Cause
    Other
    Initiated
    April 19, 2007
    Posted
    May 16, 2007
    Terminated
    June 11, 2008
    Address
    9115 Hague Rd, Indianapolis, IN, 46250-0416

    Description

    Roche PTH (parathyroid hormone test system) for use in conjunction with Roche cobas e 411, cobas e 601, Elecsys 1010, Elecsys 2010 and Modular E 170 analyzers; catalog no. 11972103122.

    Reason

    Negative bias caused by hemolysis interference at the low end of the reference range could cause erroneous diagnosis of hypoparathyroidism.

    Action

    The firm issued a letter dated 04/19/07 to all users informing them of the change in the hemoglobin interference claim.

    Distribution

    Nationwide.

    Quantity

    14,503