BEUDAMED
    FDA Recall Terminated

    ARCHITECT Folate Reagent Kit, list 6C12-20 ( 4 x 100 tests), 6C12-25 (1 x 100 tests) and 6C12-30 (4 x 500 tests), Abbott Laboratories, Abbott Park, IL 600064 U.S.A.

    Recall: Z-0783-05 · Initiated March 11, 2005

    Recall

    Recall Number
    Z-0783-05
    Event Number
    31410
    Firm
    Abbott Laboratories MPG
    FEI Number
    1415939
    Product Code
    CGN
    Status
    Terminated
    Root Cause
    Other
    Initiated
    March 11, 2005
    Posted
    April 28, 2005
    Terminated
    January 18, 2006
    Address
    100 Abbott Park Rd, Abbott Park, IL, 60064-3502

    Description

    ARCHITECT Folate Reagent Kit, list 6C12-20 ( 4 x 100 tests), 6C12-25 (1 x 100 tests) and 6C12-30 (4 x 500 tests), Abbott Laboratories, Abbott Park, IL 600064 U.S.A.

    Reason

    concentrations for normal samples generated with current reagent lots of the ARCHITECT Folate assay are lower than data generated for the package insert.

    Action

    Abbott international affilates were notified of the recall by e-mail on 03/11/2005, and requested to notifiy their customers. The letters inform the end users of the downward shift in control and/or patient results, and requested them to assess their normal and deficient ranges for their specific population, assess their quality control ranges and follow their laboratory procedures for reviewing patient results and notifying Health Care Providers that they serve. There was no U.S. distribution.

    Distribution

    Canada, Singapore, New Zealand, Germany, Hong Kong, Japan, and Australia

    Quantity

    2,521 kits