ADVIA Centaur Systems VitD 500 test — Class II medical device recall Z-1657-2014
Terminated recall by Siemens Healthcare Diagnostics, Inc, reported 2014-06-04, distributed nationwide. Samples containing fluorescein may show interference with the ADVIA Centaur¿ Systems TSH3 Ultra, Vitamin D and
| Recall number | Z-1657-2014 |
|---|---|
| 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 | 2014-04-10 |
| Classified | 2014-05-23 |
| Reported by FDA | 2014-06-04 |
| Terminated | 2016-05-27 |
| Distributed | Nationwide (US) |
| Countries outside the US | AF, AT, BE, BG, BH, CH, CY, CZ, DE, DK, DZ, EE, ES, FI, FR, GB, GR, HR, HU, IE, IL, IQ, IR, IS, IT, JO, LB, LT, LU, LV, MT, NL, NO, OM, PK, PL, PT, QA, RO, RS, SA, SE, SI, SK, TR |
| Quantity | 12,787 kits |
| Model numbers | 10631021 |
Product
ADVIA Centaur Systems VitD 500 test, Ready Pack, Catalog Number: 10631021. Intended for the invitro diagnostic use in quantitative determination of various assays on the ADVIA Centaur and ADVIA Centaur XP analyzers.
Reason for recall
Samples containing fluorescein may show interference with the ADVIA Centaur¿ Systems TSH3 Ultra, Vitamin D and the ADVIA Centaur BRAHMS Procalcitonin assays.
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-1657-2014. 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.