Class II — Potential Health Hazard

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

Oncomine Dx Target Test Recalled by Life Technologies Corporation Due to The lower concentration of the RNA panel could...

Date: February 8, 2018
Company: Life Technologies Corporation
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 Life Technologies Corporation directly.

Affected Products

Oncomine Dx Target Test, (Model No. A32451), Oncomine Dx Target RNA/DNA Panel (Model No. A32441). A qualitative In Vitro Diagnostic test.

Quantity: 30

Why Was This Recalled?

The lower concentration of the RNA panel could cause a NO CALL or FALSE NEGATIVE for the reporting of ROS1 fusion. If a physician relies on a false negative result, crizotinib could be improperly excluded from the patient's treatment regimen.

Where Was This Sold?

This product was distributed to 5 states: AZ, CA, NC, TX, VA

Affected (5 states)Not affected

About Life Technologies Corporation

Life Technologies Corporation has 13 total recalls tracked by RecallDetector.

Related Recalls

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