VIDAS Estradiol II — Class II medical device recall Z-1801-2017
Terminated recall by BioMerieux SA, reported 2017-04-19, distributed nationwide. Fulvestrant cross reacts with the VIDAS Estradiol II immunoassay and may cause falsely elevated estradiol resu
| Recall number | Z-1801-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | BioMerieux SA, Marcy L'Etoile, N/A, France |
| Recall initiated | 2017-03-17 |
| Classified | 2017-04-12 |
| Reported by FDA | 2017-04-19 |
| Terminated | 2022-02-16 |
| Distributed | Nationwide (US) |
| Quantity | 834 kits |
| Lot numbers | 1005081700, 1005172850, 1005359170 |
| Model numbers | 30431-01 |
Product
VIDAS Estradiol II, Ref 30431-01, 60 tests The VIDAS Estradiol II (E2 II) assay is intended for use on the instruments of the VIDAS family (VITEK ImmunoDiagnostic Assay System) as an automated quantitative enzyme-linked fluorescent immunoassay (ELFA) to the determination of total estradiol concentration in human serum or plasma (heparin).
Reason for recall
Fulvestrant cross reacts with the VIDAS Estradiol II immunoassay and may cause falsely elevated estradiol results in patients treated with Fulvestrant.
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-1801-2017. 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.