Stratus CS Cardiac Troponin Test (Siemens) – Potential Test Issue (2025)
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Stratus CS Acute Care cTNI TestPak.IVD test for cardiac troponin I in heparinized plasma.
Brand
Siemens Healthcare Diagnostics Inc
Lot Codes / Batch Numbers
Siemens Materials No. 10445071, UDI-DI: 0405686902174VK, Lot No. 234337002 and forward.
Products Sold
Siemens Materials No. 10445071; UDI-DI: 0405686902174VK; Lot No. 234337002 and forward.
Siemens Healthcare Diagnostics Inc is recalling Stratus CS Acute Care cTNI TestPak.IVD test for cardiac troponin I in heparinized plasma. due to Siemens Healthcare Diagnostics Inc., is recalling their Stratus CS Acute Care cTNI TestPak, an IVD test for cardiac troponin I in heparinized plasma b. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026