ADVIA Centaur Calibrator A — Class III medical device recall Z-1970-2013
Terminated recall by Siemens Healthcare Diagnostics, Inc, reported 2013-08-21, distributed nationwide. Calibrator A lot CA77 is under-recovering to the assigned target for the ADVIA Centaur Total T4 Assay.
| Recall number | Z-1970-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Siemens Healthcare Diagnostics, Inc, East Walpole, MA, United States |
| Recall initiated | 2013-06-28 |
| Classified | 2013-08-14 |
| Reported by FDA | 2013-08-21 |
| Terminated | 2014-07-25 |
| Distributed | Nationwide (US) |
| Countries outside the US | DE, SK, TR |
| Reason classes | potency |
| Model numbers | 04800735, 04800840, 10285904, 10285905, 90705A77 |
Product
ADVIA Centaur Calibrator A. Cat. #04800735, SMN 10285904 (6 pack); Cat. # 04800840, SMN 10285905 (6 pack - REF). For calibrating the following assays using the ADVIA Centaur or ACS:180 systems: FT3, T3, T4, Tup, FT4, THEO2.
Reason for recall
Calibrator A lot CA77 is under-recovering to the assigned target for the ADVIA Centaur Total T4 Assay.
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-1970-2013. 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.