Class II — Potential Health Hazard

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

Dimension Vista LOCI Estradiol Test Code E2 Catalog Number: K6463 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

Dimension Vista LOCI Estradiol Test Code E2 Catalog Number: K6463 SMN: 10489099 Product Usage: The E2 method is an in vitro diagnostic test for the quantitative measurement of estradiol in human serum and plasma on the Dimension Vista¿System. Estradiol measurements are used in the diagnosis and treatment of various hormonal sexual disorders and in assessing placental function in complicated pregnancy.

Quantity: 1945 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.

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