Siemens ADVIA Centaur Folate Cat No — Class II medical device recall Z-1564-2014
Terminated recall by Siemens Healthcare Diagnostics, Inc, reported 2014-05-14, distributed nationwide. Serum controls may go out of range low with the ADVIA Centaur ¿Systems Folate assay and a shift in whole blood
| Recall number | Z-1564-2014 |
|---|---|
| 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 | 2014-03-25 |
| Classified | 2014-05-07 |
| Reported by FDA | 2014-05-14 |
| Terminated | 2015-04-30 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, BE, BG, CH, CY, CZ, DE, DK, EE, ES, FI, FR, GB, GR, HU, IE, IL, IS, IT, LT, LU, LV, MT, NL, NO, PL, PT, QA, RO, RS, SE, SI, SK, TR |
| Quantity | 49,123 units |
| Reason classes | potency |
| Model numbers | 00203473SMN, 06367974SMN, 06891541SMN, 09132781SMN, 10310308, 10325366, 10331250, 10340209 |
| Expiration dates | 2014-03-25, 2014-05-12, 2014-08-04, 2014-09-12, 2014-10-06 |
Product
Siemens ADVIA Centaur Folate Cat No. 06891541 SMN 10325366 (500 tests) Cat No. 06367974 SMN 10310308 (100 tests) Cat No. 00203473 SMN 10331250 (Ref) (500 tests) Cat No. 09132781 SMN 10340209 (Ref) (2500 tests) For in vitro diagnostic use in the quantitative determination of folate in serum or red blood cells using the ADVIA Centaur and ADVIA Centaur XP systems
Reason for recall
Serum controls may go out of range low with the ADVIA Centaur ¿Systems Folate assay and a shift in whole blood patient may result with kit lots ending in 219 and 223
Machine access
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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.