BEUDAMED
    FDA Recall Terminated

    MULTIGENT Acetaminophen for use with Architect/Aeroset Cat. No. 2K99-20. Assay is intended for the quantitative determination of acetaminophen in human serum or plasma.

    Recall: Z-1902-2012 · Initiated May 29, 2012

    Recall

    Recall Number
    Z-1902-2012
    Event Number
    62017
    Firm
    Sekisui Diagnostics Llc
    FEI Number
    3008776041
    Product Code
    LDP
    Status
    Terminated
    Root Cause
    Storage
    Initiated
    May 29, 2012
    Posted
    June 27, 2012
    Terminated
    November 14, 2012
    Address
    31 New York Ave, Framingham, MA, 01701-8860

    Description

    MULTIGENT Acetaminophen for use with Architect/Aeroset Cat. No. 2K99-20. Assay is intended for the quantitative determination of acetaminophen in human serum or plasma.

    Reason

    Discoloration of the acetaminophen enzyme reagent (R1), generates a high calibration factor and erratic control recovery.

    Action

    Sekisui Diagnostics Llc sent an "IMPORTANT PRODUCT FIELD CORRECTION" letter dated May 29, 2012 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. The letter instructs customers to immediately stop using the affected product and to destroy any remaining inventory. A Confirmation of Notification Form was attached for customers to complete and return via fax to 902-628-6504. Contact the firm at 902-628-0984 for questions regarding this notice.

    Distribution

    Illinois

    Quantity

    1600 kits