Stratus CS Acute Care cTNI TestPak — Class II medical device recall Z-2135-2019
Terminated recall by Siemens Healthcare Diagnostics Inc, reported 2019-08-07, distributed nationwide. Potential for increased rate of false positive results and/or increased rate of random non-repeatable false po
| Recall number | Z-2135-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Siemens Healthcare Diagnostics Inc, Norwood, MA, United States |
| Recall initiated | 2019-05-29 |
| Classified | 2019-07-30 |
| Reported by FDA | 2019-08-07 |
| Terminated | 2022-05-12 |
| Distributed | Nationwide (US) |
| Quantity | 2,312 |
| Lot numbers | 238330002 |
Product
Stratus CS Acute Care cTNI TestPak, SMN 10445071 Product Usage: In vitro diagnostic test for the measurement of cardiac troponin I in heparinized plasma. Cardiac troponin I measurements can be used as an aid in the diagnosis of acute myocardial infarction (AMI).
Reason for recall
Potential for increased rate of false positive results and/or increased rate of random non-repeatable false positive results.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2135-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.