Siemens ADVIA Centaur¿ Vitamin D Total Assay SMN SMN 10699533 — Class II medical device recall Z-0398-2017
Terminated recall by Siemens Healthcare Diagnostics, Inc, reported 2016-11-23, distributed nationwide. Vitamin D Total- Change in Correlation Between Serum and Plasma Specimen Tubes- negative bias with plasma vs.
| Recall number | Z-0398-2017 |
|---|---|
| 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 | 2016-10-05 |
| Classified | 2016-11-11 |
| Reported by FDA | 2016-11-23 |
| Terminated | 2019-08-29 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AF, AR, AT, AU, BD, BE, BH, BR, CA, CH, CL, CN, CO, CY, CZ, DE, DK, DZ, EC, EG, ES, FI, FR, GB, GR, GT, HK, HR, HU, ID, IN, IQ, IT, JO, JP, KR, LB, LK, LT, LU, LV, MT, MX, MY, NL, NO, NP, NZ, OM, PH, PK, PL, PT, PY, QA, RO, RS, SA, SE, SG, SK, TR, TW, UY, VN, ZA |
| Quantity | 37,437 kits |
Product
Siemens ADVIA Centaur¿ Vitamin D Total Assay SMN SMN 10699533 (500 test)
Reason for recall
Vitamin D Total- Change in Correlation Between Serum and Plasma Specimen Tubes- negative bias with plasma vs. serum samples
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-0398-2017. 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.