BEUDAMED
    FDA Enforcement Class II Terminated

    Stratus CS Acute Care cTNI TestPak, SMN 10445071 Product Usage: In vitro diagnostic test for the measurement of cardiac troponin I in heparinized plasma. Cardiac troponin I measurements can be used as an aid in the diagnosis of acute myocardial infarction (AMI).

    Recall: Z-2135-2019 · Reported August 7, 2019

    Enforcement

    Recall Number
    Z-2135-2019
    Event ID
    82990
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Siemens Healthcare Diagnostics Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 7, 2019
    Initiation Date
    May 29, 2019
    Classification Date
    July 30, 2019
    Termination Date
    May 12, 2022
    Address
    2 Edgewater Dr, N/A, Norwood, MA, 02062-4637, United States

    Description

    Stratus CS Acute Care cTNI TestPak, SMN 10445071 Product Usage: In vitro diagnostic test for the measurement of cardiac troponin I in heparinized plasma. Cardiac troponin I measurements can be used as an aid in the diagnosis of acute myocardial infarction (AMI).

    Reason

    Potential for increased rate of false positive results and/or increased rate of random non-repeatable false positive results.

    Code Info

    Lot # 238330002 forward Expiration Dates - May 25, 2019 - November 2, 2019

    Distribution

    US Nationwide Distribution

    Quantity

    2312