BEUDAMED
    FDA Recall Terminated

    Roche Cortisol reagent for use in conjunction with Roche cobas e 411, cobas e 601, Elecsys 1010, Elecsys 2010 and Modular E 170 analyzers; Catalog no. 11875116122. in vitro diagnostic.

    Recall: Z-0977-2007 · Initiated May 15, 2007

    Recall

    Recall Number
    Z-0977-2007
    Event Number
    37764
    Firm
    Roche Diagnostics Corp.
    FEI Number
    1823260
    Product Code
    NHG
    Status
    Terminated
    Root Cause
    Other
    Initiated
    May 15, 2007
    Posted
    June 28, 2007
    Terminated
    June 11, 2008
    Address
    9115 Hague Rd, Indianapolis, IN, 46250-0416

    Description

    Roche Cortisol reagent for use in conjunction with Roche cobas e 411, cobas e 601, Elecsys 1010, Elecsys 2010 and Modular E 170 analyzers; Catalog no. 11875116122. in vitro diagnostic.

    Reason

    The test is not as sensitive, or as precise between runs, as claimed in the labeling. Low concentrations are observed only in saliva samples.

    Action

    The firm notified consignees via letter dated 5/15/07 and notifed them of the changes to functional sensitivity and between-run precision claims.

    Distribution

    Nationwide.

    Quantity

    6051