BEUDAMED
    FDA Enforcement Class III Terminated

    ARCHITECT STAT High Sensitive Troponin-I Calibrators - Product Usage: The ARCHITECT STAT High Sensitive Troponin-I Controls are for the estimation of test precision and the detection of systematic analytical deviations of the ARCHITECT i System with STAT protocol capability when used for the quantitative determination of cardiac troponin I (cTnI) in human serum and plasma with the ARCHITECT STAT High Sensitive Troponin-I reagent kit.

    Recall: Z-1360-2019 · Reported May 22, 2019

    Enforcement

    Recall Number
    Z-1360-2019
    Event ID
    82590
    Classification
    Class III
    Status
    Terminated
    Product Type
    Devices
    Firm
    Abbott Laboratories
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    May 22, 2019
    Initiation Date
    April 9, 2019
    Classification Date
    May 16, 2019
    Termination Date
    December 20, 2019
    Address
    100 Abbott Park Rd Bldg Ap8b, Abbott Park, IL, 60064-3502, United States

    Description

    ARCHITECT STAT High Sensitive Troponin-I Calibrators - Product Usage: The ARCHITECT STAT High Sensitive Troponin-I Controls are for the estimation of test precision and the detection of systematic analytical deviations of the ARCHITECT i System with STAT protocol capability when used for the quantitative determination of cardiac troponin I (cTnI) in human serum and plasma with the ARCHITECT STAT High Sensitive Troponin-I reagent kit.

    Reason

    Devices were delivered without the required dry ice.

    Code Info

    LN 3P25-02; Lot 93284UIOO

    Distribution

    Distribution to Latvia.

    Quantity

    3 units