Siemens ADVIA Centaur Folate — Class II medical device recall Z-0830-2020
Terminated recall by Siemens Healthcare Diagnostics, Inc, reported 2020-01-29, distributed nationwide. Homocysteine Assay May Cause Elevated Results in the Folate Assay
| Recall number | Z-0830-2020 |
|---|---|
| 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 | 2019-07-22 |
| Classified | 2020-01-21 |
| Reported by FDA | 2020-01-29 |
| Terminated | 2025-02-14 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AT, BE, BH, CH, CZ, DE, DK, EG, ES, FR, GR, HU, IE, IL, IR, IT, JO, LT, NL, NO, NP, PK, PL, PT, QA, RO, RS, SE, SI, SK, TR |
| Quantity | 10,928 kits |
| Reason classes | potency |
Product
Siemens ADVIA Centaur Folate (500 Test Kit)-for IVD of folate in serum or red blood cells SMN: 10325366
Reason for recall
Homocysteine Assay May Cause Elevated Results in the Folate 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-0830-2020. 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.