BEUDAMED
    FDA Recall Terminated

    ARCHITECT Lactic Acid Part # 09D891T21 The Lactic Acid assay is used for the quantitation of lactic acid in human plasma.

    Recall: Z-0379-2017 · Initiated October 11, 2016

    Recall

    Recall Number
    Z-0379-2017
    Event Number
    75448
    Firm
    Abbott Laboratories
    FEI Number
    1415939
    Product Code
    KHP
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    October 11, 2016
    Posted
    November 9, 2016
    Terminated
    May 17, 2017
    Address
    100 Abbott Park Rd, Abbott Park, IL, 60064-3502

    Description

    ARCHITECT Lactic Acid Part # 09D891T21 The Lactic Acid assay is used for the quantitation of lactic acid in human plasma.

    Reason

    Abbott has identified negative interference from the drug N-Acetyl Cysteine (NAC) with the ARCHITECT Lactic Acid reagent (LN 9D89-21).

    Action

    Abbott Laboratories sent an Product Correction Immediate Action Required letter dated October 10, 2016, to all affected customers. Please review this letter with your Medical Director Taking the above information into consideration, you may continue to use ARCHITECT Lactic Acid reagent (LN 9D89-21) Please complete and return the Customer Reply Form If you have forwarded the product listed above to other laboratories, please inform them of this Product Correction and provide to them a copy of this letter Please retain this letter for your laboratory records. If you or any of the health care providers you serve have any questions regarding this information, U.S. Customers please contact Customer Service at 1-877-4ABBOTT (available 24 hours a day, 7 days a week). Customers outside the U.S., please contact your local area Customer Service. For further questions please call (847) 937-2550.

    Distribution

    Nationwide and Worldwide Distribution.

    Quantity

    26, 837 kits