BEUDAMED
    FDA Recall Open, Classified

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

    Recall: Z-1673-2025 · Initiated March 31, 2025

    Recall

    Recall Number
    Z-1673-2025
    Event Number
    96631
    Firm
    Siemens Healthcare Diagnostics Inc
    FEI Number
    3002637618
    Product Code
    JHX
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    March 31, 2025
    Posted
    April 25, 2025
    Address
    2 Edgewater Dr, Norwood, MA, 02062-4637

    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.

    Action

    An Urgent Medical Device Correction notice dated March 2025 was mailed to consignees. The notice instructed consignees to review the provided notification with their medical director to determine the appropriate course of action. Siemens will reimburse users for repeat tests and discarded units associated with this recall; consignees should contact the Customer Care Center for reimbursement. If product was further distributed, Siemens asks that the recall notification be forwarded. The recall notification is to be retained with laboratory records and forwarded to those who use the recalled devices. Consignees with any questions can contact Siemens Healthineers Technical Solutions Center at 977-229-3711.

    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