IMMULITE 2000 EstradiolTest Code E2 Catalog Number: L2KE22 — Class II medical device recall Z-1243-2016
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-1243-2016 |
|---|---|
| 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 | 9,334 units |
| Model numbers | L2KE22 |
Product
IMMULITE 2000 EstradiolTest Code E2 Catalog Number: L2KE22, L2KE22 (D), L2KE26, L2KE26 (D) SMN: 10381178, 10702833, 10381177, 10702834 Product Usage: For in vitro diagnostic use the IMMULITE¿2000 systems Analyzers- for the quantitative measurement of estradiol in serum, as an aid in the diagnosis and treatment of various sexual disorders
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-1243-2016. 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.