ADVIA Centaur Folate 500 test kit- For in vitro diagnostic use in the… — Class II medical device recall Z-1153-2023
Ongoing recall by Siemens Healthcare Diagnostics, Inc., reported 2023-03-01, distributed nationwide. Negative bias occurred when whole blood calibration (Atellica IM Fol or ADVIA Centaur FolateBA/FolBA) used to
| Recall number | Z-1153-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Siemens Healthcare Diagnostics, Inc., East Walpole, MA, United States |
| Recall initiated | 2023-01-09 |
| Classified | 2023-02-21 |
| Reported by FDA | 2023-03-01 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AT, BE, BG, BH, CH, CY, CZ, DE, DK, EE, ES, FI, FR, GR, HR, HU, IE, IL, IR, IT, JO, KE, LT, LV, MA, MT, NL, NO, NP, OM, PK, PL, PT, QA, RO, RS, SE, SI, SK, TN, TR, UA |
| Quantity | 7,884 kits |
| UPC / GTIN / UDI-DI | 00630414450940 |
| Lot numbers | 16276336, 21334336, 22079336, 27946338, 41225342, 62966344 |
Product
ADVIA Centaur Folate 500 test kit- For in vitro diagnostic use in the quantitative determination of folate in human serum and red blood cells. Siemens Material Number (SMN): 10325366
Reason for recall
Negative bias occurred when whole blood calibration (Atellica IM Fol or ADVIA Centaur FolateBA/FolBA) used to test 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-1153-2023. 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.