[pending] Stratus CS Acute Care cTNI TestPak.IVD test for cardiac troponin I in heparinized plasma.
Pending LLM rewrite. Source: FDA_DEVICE Z-1673-2025.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Pending LLM scoring against the rubric.
Plain-English summary
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.
The recalled product
- Product
- Stratus CS Acute Care cTNI TestPak.IVD test for cardiac troponin I in heparinized plasma.
- Manufacturer
- Siemens Healthcare Diagnostics Inc
- Category
- Medical Device — Devices
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Siemens Materials No. 10445071
- UDI-DI: 0405686902174VK
- Lot No. 234337002 and forward.
Distribution
Distributed nationwide across the United States.
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