ADVIA Centaur Enhanced Estradiol — Class II medical device recall Z-1023-2022
Ongoing recall by Siemens Healthcare Diagnostics, Inc., reported 2022-05-11, distributed nationwide. Falsely Elevated Results Observed with Plasma Specimens, could lead a clinician to misinterpret patient result
| Recall number | Z-1023-2022 |
|---|---|
| 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 | 2022-03-03 |
| Classified | 2022-04-29 |
| Reported by FDA | 2022-05-11 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AT, BE, BG, BR, CH, CY, DK, EE, EG, ES, FI, FR, GB, GR, IE, IL, IN, IT, LT, LV, MA, MT, NL, NO, NP, PL, PT, PY, QA, RO, SE, SK, TR, UA |
| Quantity | 2,315 units |
| UPC / GTIN / UDI-DI | 00630414573342 |
Product
ADVIA Centaur Enhanced Estradiol (eE2) 100T - In vitro diagnostic use in the quantitative determination of estradiol SMN: 10490889 All lots
Reason for recall
Falsely Elevated Results Observed with Plasma Specimens, could lead a clinician to misinterpret patient results
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-1023-2022. 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.