FDA Device recall Z-1673-2025
Stratus CS Acute Care cTNI TestPak.IVD test for cardiac troponin I in heparinized plasma
- FDA Device
- Class II
- ongoing
- Published 2025-05-07
On 2025-05-07 the FDA classified a Class II recall of Stratus CS Acute Care cTNI TestPak.IVD test for cardiac troponin I in heparinized plasma by Siemens Healthcare Diagnostics, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1673-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-03-31 |
| Published | 2025-05-07 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Siemens Healthcare Diagnostics |
| Distribution | US |
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.
Identifiers
| code_info | Siemens Materials No. 10445071; UDI-DI: 0405686902174VK; Lot No. 234337002 and forward. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
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Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1673-2025%22
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