Recall Z-1673-2025— Siemens Healthcare Diagnostics Inc

Name: FDA recall Z-1673-2025
Creator: U.S. Food and Drug Administration
Published: 2025-03-31

Class II · Ongoing

Class II FDA medical device recall by Siemens Healthcare Diagnostics Inc, initiated 2025-03-31. It names one FDA 510(k) clearance: K051650. Product: 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..

Recalling firm: Siemens Healthcare Diagnostics Inc
Classification: Class II
Status: Ongoing
Initiated: 2025-03-31
Firm location: Norwood, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K051650 — STRATUS CS ACUTE CARE MB ISOENZYME OF CREATINE KINASE (CKMB) TEST PAK; STRATUS CS ACUTE CARE CKMB TESTPAK.Dade Behring, Inc.·cleared 2005-09-08

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.