IMMULITE 1000 Systems E2 Estradiol Catalog #: US: LKE21 — Class II medical device recall Z-1513-2020

Terminated recall by Siemens Healthcare Diagnostics, Inc., reported 2020-03-25, distributed nationwide. Due to high discordant Estradiol results which.potentially affects all patient populations, A falsely elevated

Recall number	`Z-1513-2020`
Product type	Medical device
Classification	Class II
Status	Terminated
Voluntary or mandated	Voluntary
Recalling firm	Siemens Healthcare Diagnostics, Inc., Tarrytown, NY, United States
Recall initiated	2020-02-05
Classified	2020-03-18
Reported by FDA	2020-03-25
Terminated	2021-11-18
Distributed	Nationwide (US)
Quantity	2,267 kits
UPC / GTIN / UDI-DI	`00630414947891`, `00630414966151`
Model numbers	`LKE21`

Product

IMMULITE 1000 Systems E2 Estradiol Catalog #: US: LKE21(D) and OUS: LKE21 - Product Usage: For in vitro diagnostic use with the IMMULITE 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

Due to high discordant Estradiol results which.potentially affects all patient populations, A falsely elevated estradiol level could lead a clinician to misinterpret a patient as pre-menopausal when truly post- menopausal. This may lead to delayed initiation of a potentially beneficial drug and/or administration of an unnecessary drug in the treatment for hormone receptor positive advanced or metastatic breast cancer.

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-1513-2020. 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.