Class II — Potential Health Hazard

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

FGFR RGQ RT-PCR Kit (RUO Recalled by Qiagen Sciences LLC Due to Increased occurrence rate of false positive results, lead...

Date: July 20, 2022
Company: Qiagen Sciences LLC
Status: Ongoing
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

FGFR RGQ RT-PCR Kit (RUO, not IVD) REF 8747010

Quantity: 9 kits

Why Was This Recalled?

Increased occurrence rate of false positive results, lead to a false positive sample result that could subsequently be incorrectly reported from the laboratory. A false positive result could lead to the risk of the patient being exposed to an inappropriate or suboptimal anti-cancer treatment and/or unnecessarily experiencing side effects

Where Was This Sold?

This product was distributed to 4 states: IN, MN, NC, TX

Affected (4 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