Siemens Acute Care CTNI TestPak-in vitro diagnostic test for the… — Class II medical device recall Z-0609-2016
Terminated recall by Siemens Healthcare Diagnostics Inc, reported 2016-01-13, distributed nationwide. Stratus CS Cartridge Barcode labels may not scan on the Stratus CS systems
| Recall number | Z-0609-2016 |
|---|---|
| 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 | 2015-11-11 |
| Classified | 2016-01-07 |
| Reported by FDA | 2016-01-13 |
| Terminated | 2016-09-23 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AT, AU, BD, CA, CH, CZ, DE, DK, DZ, ES, FI, FR, GB, GR, HR, IE, IN, IT, JP, MY, PL, PT, RO, SA, SE, SI, TR, TW, ZA |
| Quantity | 5,558 |
| Reason classes | labeling |
| Lot numbers | 235151002, 235159002, 235166002, 235173002, 235208002, 235215002, 235222002, 235229002, 235236002, 235243002, 235250002, 235257002, 235278002, 235285002 |
Product
Siemens Acute Care CTNI TestPak-in vitro diagnostic test for the measurement of cardiac troponin I in heparinized plasma Catalog Number: CCTNI SMN: 10445071
Reason for recall
Stratus CS Cartridge Barcode labels may not scan on the Stratus CS systems
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-0609-2016. 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.