Drug recall
Stratus CS Acute Care cTNI TestPak.IVD test for cardiac troponin I in heparinized plasma.
FDA recall event 96631 · Class II · Siemens Healthcare Diagnostics Inc
Key facts
| Event ID | 96631 |
|---|---|
| Recall numbers | Z-1673-2025 |
| Recalling firm | Siemens Healthcare Diagnostics Inc |
| Product type | Devices |
| Products | Stratus CS Acute Care cTNI TestPak.IVD test for cardiac troponin I in heparinized plasma. |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| 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… |
| Initiation date | Mar 31, 2025 |
| Report date | May 7, 2025 |
| City | Norwood |
| State | MA |
| Country | United States |
| FEI number | 3002637618 |
At a glance
- 1–9 Products in this recall
- None FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: