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 2000 EstradiolTest Code E2 Catalog Number: L2KE22 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 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

Quantity: 9334 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