BEUDAMED
    FDA Enforcement Class II Ongoing

    Stratus CS Acute Care cTNI TestPak.IVD test for cardiac troponin I in heparinized plasma.

    Recall: Z-1673-2025 · Reported May 7, 2025

    Enforcement

    Recall Number
    Z-1673-2025
    Event ID
    96631
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Siemens Healthcare Diagnostics Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 7, 2025
    Initiation Date
    March 31, 2025
    Classification Date
    April 25, 2025
    Address
    2 Edgewater Dr, Norwood, MA, 02062-4637, United States

    Description

    Stratus CS Acute Care cTNI TestPak.IVD test for cardiac troponin I in heparinized plasma.

    Reason

    Siemens Healthcare Diagnostics Inc., is recalling their Stratus CS Acute Care cTNI TestPak, an IVD test for cardiac troponin I in heparinized plasma by removal. The reason for the recall is an increased occurrence of random non-repeatable false positive cardiac Troponin l(cTnI) results at any point during the TestPaks shelf life when using the Stratus CS cTnI Acute Care Testpak.

    Code Info

    Siemens Materials No. 10445071; UDI-DI: 0405686902174VK; Lot No. 234337002 and forward.

    Distribution

    Worldwide - US Nationwide distribution in the states of CA, IL, KS, MI, MO, NJ, NY, OH, OK, PA, SC & WI. The countries of Austria, Canada, Chile, France, Germany, Iraq, Italy, Malaysia, North Macedonia, Saudi Arabia, Serbia, Slovenia, Spain, Sweden, Switzerland & Vietnam.

    Quantity

    367 units