BEUDAMED
    FDA Recall Terminated

    Roche/Hitachi brand lactate reagent for the quantitative determination of L-lactate in plasma, cerebrospinal fluid or whole blood. Catalog # 1822837.

    Recall: Z-0028-04 · Initiated September 2, 2003

    Recall

    Recall Number
    Z-0028-04
    Event Number
    27164
    Firm
    Roche Diagnostics Corp.
    FEI Number
    1823260
    Product Code
    LNN
    Status
    Terminated
    Root Cause
    Other
    Initiated
    September 2, 2003
    Posted
    October 15, 2003
    Terminated
    December 10, 2003
    Address
    9115 Hague Road, Indianapolis, IN, 46250-0457

    Description

    Roche/Hitachi brand lactate reagent for the quantitative determination of L-lactate in plasma, cerebrospinal fluid or whole blood. Catalog # 1822837.

    Reason

    Patient samples with very high lactate values may falsely be reported as within the normal range without the instrument giving a warning flag to the technician.

    Action

    Recall letters were sent to U.S. customers on 9/2/03 instructing them not to run lactate with these analyzers. An update notification letter was sent on or about 9/18/03 telling customers to discontinue use of the product for manual lactate determinations.

    Distribution

    United States, Canada and Germany

    Quantity

    21958