IMMULITE 1000 Estradiol Test Code E2 Catalog Number: LKE21 — Class II medical device recall Z-1242-2016
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-1242-2016 |
|---|---|
| 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 | 9,251 units |
| Model numbers | LKE21 |
Product
IMMULITE 1000 Estradiol Test Code E2 Catalog Number: LKE21, LKE21(D), LKE25 SMN: 10381132, 10702832, 10381142 Product Usage: For in vitro diagnostic use with the IMMULITE¿ and IMMULITE 1000 Analyzers - for the quantitative measurement of estradiol in serum, as an aid in the diagnosis and treatment of various hormonal 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-1242-2016. 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.