BEUDAMED
    FDA Recall Terminated

    SYNCHRON Clinical Systems Lipase (LIPA) Reagent; Classification name: 862.1465

    Recall: Z-0262-5 · Initiated October 25, 2004

    Recall

    Recall Number
    Z-0262-5
    Event Number
    30362
    Firm
    Beckman Coulter Inc
    FEI Number
    2050012
    Product Code
    CHI
    Status
    Terminated
    Root Cause
    Other
    Initiated
    October 25, 2004
    Posted
    November 30, 2004
    Terminated
    June 17, 2005
    Address
    200 S Kraemer Blvd, Brea, CA, 92822-6208

    Description

    SYNCHRON Clinical Systems Lipase (LIPA) Reagent; Classification name: 862.1465

    Reason

    Beckman Coulter has confirmed that occasionally a cuvette may be skipped during the SYNCHRON Lipase Wash (LIWA) procedure. If this occurs, there is the potential for carryover into the SYNCHRON Lipase (LIPA) assay, resulting ina substantial positive bias affecting Lipase (LIPA) results.

    Action

    The week of 10/25/2004, a product corrective action (PCA) letter was mailed vis U.S. mail to all customers shipped LIPA reagent for the 24 months preceding the discovery of the issue. Customers instructed to repeat any sample that produces a lipase value of > 170 U/L that cannot be confirmed by patient history.

    Distribution

    US and Canada

    Quantity

    6,698