ADVIA Centaur¿ Systems TnI-Ultra assay — Class II medical device recall Z-1991-2014
Terminated recall by Siemens Healthcare Diagnostics, Inc, reported 2014-07-09, distributed nationwide. The solid phase reagent in some of the ADVIA Centaur¿ TnI -Ultra ReadyPacks¿, lot 084, is darker in appearance
| Recall number | Z-1991-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Siemens Healthcare Diagnostics, Inc, East Walpole, MA, United States |
| Recall initiated | 2014-05-30 |
| Classified | 2014-07-02 |
| Reported by FDA | 2014-07-09 |
| Terminated | 2016-02-26 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, AU, BE, BG, BH, BR, CA, CH, CL, CN, CO, CR, CY, CZ, DK, EC, EE, EG, ES, FI, FR, GB, GR, HK, HR, ID, IE, IL, IN, IS, IT, JP, KR, LB, LK, LV, MT, MX, MY, NL, NO, NZ, PE, PH, PK, PL, PT, PY, QA, RO, RS, SA, SE, SG, SI, SK, TH, TN, TR, TW, UY, VN, ZA |
| Quantity | 34,283 kits |
| Model numbers | 02789602 |
Product
ADVIA Centaur¿ Systems TnI-Ultra assay; Catalog Number 02789602 (100 tests), SMN 10317708 and 02790309 (500 tests), SMN 10317790
Reason for recall
The solid phase reagent in some of the ADVIA Centaur¿ TnI -Ultra ReadyPacks¿, lot 084, is darker in appearance, creating a potential for incorrect control and patient 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-1991-2014. 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.