medical Class II Updated 2025-05-07

Siemens Healthcare Diagnostics Inc recalls Stratus CS Acute Care cTNI TestPak.IVD test for cardiac trop

Recalled Product

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


Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Siemens Materials No. 10445071; UDI-DI: 0405686902174VK; Lot No. 234337002 and forward.
View official government recall

Looking for safe alternatives?

Browse certified-safe products in this category on Amazon →