BEUDAMED
    FDA Enforcement Class II 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 · Reported July 4, 2012

    Enforcement

    Recall Number
    Z-1902-2012
    Event ID
    62017
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Sekisui Diagnostics Llc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 4, 2012
    Initiation Date
    May 29, 2012
    Classification Date
    June 27, 2012
    Termination Date
    November 14, 2012
    Address
    31 New York Ave, Framingham, MA, 01701-8860, United States

    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.

    Code Info

    Lot 41928UQ11 {exp 2013-01 -31 )

    Distribution

    Illinois

    Quantity

    1600 kits