VITROS Immunodiagnostic Products Estradiol Reagent Pack — Class II medical device recall Z-2352-2016
Terminated recall by ORTHO-CLINICAL DIAGNOSTICS, reported 2016-08-17, distributed nationwide. Ortho Clinical Diagnostics has issued a recall of their VITROS immunodiagnostics Estradiol Reagent assay. The
| Recall number | Z-2352-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | ORTHO-CLINICAL DIAGNOSTICS, Bridgend, United Kingdom |
| Recall initiated | 2016-07-14 |
| Classified | 2016-08-05 |
| Reported by FDA | 2016-08-17 |
| Terminated | 2018-06-08 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, BR, CA, CL, CN, CO, DE, ES, FR, GB, IN, IT, JP, MX, PA, PL, SG, VE |
| Reason classes | potency |
| UPC / GTIN / UDI-DI | 10758750005017 |
| Lot numbers | 1470 |
| Expiration dates | 2016-08-02, 2016-08-05, 2016-10-10, 2016-11-01, 2017-03-09, 2017-03-14, 2017-03-29 |
Product
VITROS Immunodiagnostic Products Estradiol Reagent Pack, Unique Device Identifier No. 10758750005017, REF/Catalog Number/Product Code 855 2630; IVD -- Ortho-Clinical Diagnostics, Pencoed, Bridgend CF35 5PZ, UK --- The VITROS Estradiol test is performed using the VITROS Estradiol Reagent Pack and Calibrators on VITROS ECi/ECiQ Immunodiagnostic Systems, VITROS 3600 Immunodiagnostic Systems and VITROS 5600 Integrated Systems.
Reason for recall
Ortho Clinical Diagnostics has issued a recall of their VITROS immunodiagnostics Estradiol Reagent assay. The firm was made aware of a potential cross-reactivity between the drug Fulvestrant and theVITROS Immunodiagnostic Estradiol Reagent assay. The firm conducted an internal investigation and was able to confirm biased positive (ranging from 1303-4046%) on Estradiol results, obtained from postmenopausal females taking 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-2352-2016. 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.