Turbo Troponin I For in vitro diagnostic use for the quantitative… — Class II medical device recall Z-0801-2015
Terminated recall by Siemens Healthcare Diagnostics, Inc., reported 2014-12-24, distributed in CO, FL, MN, MT, NY.
| Recall number | Z-0801-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Siemens Healthcare Diagnostics, Inc., Tarrytown, NY, United States |
| Recall initiated | 2014-10-27 |
| Classified | 2014-12-12 |
| Reported by FDA | 2014-12-24 |
| Terminated | 2017-03-10 |
| Distributed | CO, FL, MN, MT, NY |
| Countries outside the US | AR, BG, BO, BR, CL, CZ, DE, DZ, EC, EG, HU, IN, IT, LT, LV, PK, PL, RO, RS, SK, TH, TN, UY, ZA |
| Lot numbers | 319, 321, 322, 323, D319, D321, D322 |
Product
Turbo Troponin I For in vitro diagnostic use for the quantitative measurement of troponin I in serum, heparinized or EDTA plasma, as an aid in the diagnosis of acute myocardial infarction (AMI).
Reason for recall
Not stated by FDA.
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-0801-2015. 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.