BEUDAMED
    FDA Recall Terminated

    Clinical Chemistry Lipase, List Numbers: 7D80-20 and 7D80-30

    Recall: Z-1232-2007 · Initiated June 1, 2007

    Recall

    Recall Number
    Z-1232-2007
    Event Number
    38635
    Firm
    Abbott Laboratories Inc.
    FEI Number
    2018433
    Product Code
    CHI
    Status
    Terminated
    Root Cause
    Other
    Initiated
    June 1, 2007
    Posted
    September 18, 2007
    Terminated
    April 5, 2012
    Address
    820 Mission St, South Pasadena, CA, 91030-3142

    Description

    Clinical Chemistry Lipase, List Numbers: 7D80-20 and 7D80-30

    Reason

    Lipase results are falsely elevated when a MULTIGENT Acetaminophen test is pipetted immediately before a Lipase test from the same sample cup or tube on the ARCHITECT c8000.

    Action

    The firm initiated the recall on 06/01/2007 by sending recall letters with attached Customer Reply form via FedEx to each direct account that received the recalled product. Customers were informed of the issue and given instructions for modification to the SmartWash feature in the Lipase Assay Configuration in order to prevent Acetaminophen from contaminating Lipase.

    Distribution

    Worldwide, including USA, Australia, Brazil, Canada, Chile, El Salvador, Dominican Republic, Ecuador, Germany, Hong Kong, Japan, Mexico, New Zealand, Panama, Puerto Rico, Singapore, South Korea, Thailand, and Venezuela.

    Quantity

    7260