BEUDAMED
    FDA Enforcement Class II Ongoing

    ARCHITECT STAT Myoglobin Calibrators, RES 2K43-01 The ARCHITECT STAT Myoglobin Calibrators are for the calibration of the ARCHITECT iSystem with STAT protocol capability when used for the quantitative determination of myoglobin in human serum and plasma.

    Recall: Z-0891-2022 · Reported April 13, 2022

    Enforcement

    Recall Number
    Z-0891-2022
    Event ID
    89794
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Abbott Laboratories
    Voluntary / Mandated
    Voluntary: Firm initiated
    Report Date
    April 13, 2022
    Initiation Date
    March 8, 2022
    Classification Date
    April 7, 2022
    Address
    100 Abbott Park Rd Bldg Ap8b, Abbott Park, IL, 60064-3502, United States

    Description

    ARCHITECT STAT Myoglobin Calibrators, RES 2K43-01 The ARCHITECT STAT Myoglobin Calibrators are for the calibration of the ARCHITECT iSystem with STAT protocol capability when used for the quantitative determination of myoglobin in human serum and plasma.

    Reason

    This calibrator lot did not meet acceptance criteria during ongoing stability testing. When a calibration is performed with this lot, controls may exceed the specified range in the Instructions for Use (IFU).

    Code Info

    UDI: (01)00380740003272(17)220531(10)166000

    Distribution

    Worldwide Distribution: US (nationwide) and OUS (foreign) including countries of: AUSTRIA, BELGIUM, BOSNIA AND HERZEGOVI, CROATIA, CYPRUS, CZECH REPUBLIC, DENMARK, FRANCE, GERMANY, GREECE, IRAQ, ITALY, KAZAKHSTAN, LITHUANIA, LUXEMBOURG, MACEDONIA, MOROCCO, PANAMA, PORTUGAL, QATAR, ROMANIA, SAUDI ARABIA, SOUTH AFRICA, SWEDEN, SWITZERLAND, and TURKEY

    Quantity

    402 kits