Siemens ADVIA Centaur Enhance Estradiol Test Code eE2 Catalog Number:… — Class II medical device recall Z-1240-2016
Terminated recall by Siemens Healthcare Diagnostics, Inc, reported 2016-03-30, distributed nationwide. The drug fulvestrant (Faslodex¿) may cause falsely elevated estradiol results.
| Recall number | Z-1240-2016 |
|---|---|
| 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 | 2016-01-13 |
| Classified | 2016-03-24 |
| Reported by FDA | 2016-03-30 |
| Terminated | 2018-01-08 |
| Distributed | Nationwide (US) |
| Quantity | 33,604 units |
| Model numbers | 10490889, 10491445, 10697757 |
Product
Siemens ADVIA Centaur Enhance Estradiol Test Code eE2 Catalog Number: 10490889, 10491445, 10697757 Product Usage: For in vitro diagnostic use in the quantitative determination of estradiol in human serum and plasma (heparinized and EDTA) using the ADVIA Centaur¿, ADVIA Centaur XP, ADVIA Centaur XPT and ADVIA Centaur CP systems.
Reason for recall
The drug fulvestrant (Faslodex¿) may cause falsely elevated estradiol 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-1240-2016. 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.