Siemens ADVIA Centaur¿ Calibrator U — Class II medical device recall Z-2899-2016
Terminated recall by Siemens Healthcare Diagnostics, Inc, reported 2016-10-05, distributed nationwide. Failure of analytical sensitivity with Calibrator U kit lots ending in 63 and 64 and a drift from the internal
| Recall number | Z-2899-2016 |
|---|---|
| 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 | 2016-08-08 |
| Classified | 2016-09-28 |
| Reported by FDA | 2016-10-05 |
| Terminated | 2018-10-03 |
| Distributed | Nationwide (US) |
| Countries outside the US | AR, AU, BR, CA, CL, CN, EC, IN, JP, KR, MX, MY, PE, PH, SA, SG, TW, VN, ZA |
| Quantity | 2,248 kits |
Product
Siemens ADVIA Centaur¿ Calibrator U, For in vitro diagnostic use in calibrating the following assays using ADVIA Centaur"' systems: Myoglobin cTnl Cat No. ADVIA Centaur Calibrator U (2 Pack) - 03684480 (SMN 1 0309996)
Reason for recall
Failure of analytical sensitivity with Calibrator U kit lots ending in 63 and 64 and a drift from the internal standardization
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-2899-2016. 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.