BEUDAMED
    FDA Recall Terminated

    B12 Reagent (6C09-20 and 6C09-25) for use with the ARCHITECT i2000 and i2000SR Analyzers, List numbers 8C89-01 and 3M74-01. The reagent is manufactured by Abbott Laboratories, Abbott Park, IL. The ARCHITECT instrument is manufactured by Abbott Laboratories, Irving Texas

    Recall: Z-0435-05 · Initiated December 14, 2001

    Recall

    Recall Number
    Z-0435-05
    Event Number
    30764
    Firm
    Abbott Laboratories, Inc
    FEI Number
    1628664
    Product Code
    LID
    Status
    Terminated
    Root Cause
    Other
    Initiated
    December 14, 2001
    Posted
    January 26, 2005
    Terminated
    November 2, 2005
    Address
    1921 Hurd Drive PO Box 152020, Irving, TX, 75038

    Description

    B12 Reagent (6C09-20 and 6C09-25) for use with the ARCHITECT i2000 and i2000SR Analyzers, List numbers 8C89-01 and 3M74-01. The reagent is manufactured by Abbott Laboratories, Abbott Park, IL. The ARCHITECT instrument is manufactured by Abbott Laboratories, Irving Texas

    Reason

    Falsely elevated B-hCG results can occur when running B12 and B-hCG assays on the same analyzer due to carryover. B-12 results are not impacted.

    Action

    The firm initiated the recall via letter on December 14 and 16, 2004 directing consignees to perform the two tests on different machines or to contact the customer service representative in the event the consignee only has one machine.

    Distribution

    The B12 reagent was only distributed to foreign countries including Canada, Germany, Hong Kong, Japan, Dingapore, Australia, and New Zealand

    Quantity

    6860 units