Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

IMMULITE 1000 Estradiol Test Code E2 Catalog Number: LKE21 Recalled by Siemens Healthcare Diagnostics, Inc Due to The drug fulvestrant (Faslodex¿) may cause falsely elevated...

Date: January 13, 2016
Company: Siemens Healthcare Diagnostics, Inc
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Siemens Healthcare Diagnostics, Inc directly.

Affected Products

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

Quantity: 9251 units

Why Was This Recalled?

The drug fulvestrant (Faslodex¿) may cause falsely elevated estradiol results.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Siemens Healthcare Diagnostics, Inc

Siemens Healthcare Diagnostics, Inc has 118 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report