Class II — Potential Health Hazard

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

therascreen EGFR RGQ PCR Kit (24) Recalled by Qiagen Sciences LLC Due to There is a risk for a false mutation...

Date: April 8, 2020
Company: Qiagen Sciences LLC
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 Qiagen Sciences LLC directly.

Affected Products

therascreen EGFR RGQ PCR Kit (24), Reference Number REF 870121

Quantity: 530 kits within expiry

Why Was This Recalled?

There is a risk for a false mutation positive result in rare cases resulting from a fluorescence artefact. In these rare cases, the controls pass correctly, while a fluorescence artefact in the mutation assay causes an incorrect valid mutation positive result.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Qiagen Sciences LLC

Qiagen Sciences LLC has 21 total recalls tracked by RecallDetector.

Related Recalls

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