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 KRAS RGQ PCR Kit (24) Model Number(s): REF 870021 (US IVD) Recalled by Qiagen Sciences LLC Due to False positive or false negative G12C (12CYS) mutation...

Date: February 25, 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

therascreen KRAS RGQ PCR Kit (24) Model Number(s): REF 870021 (US IVD)

Quantity: 435 kits

Why Was This Recalled?

False positive or false negative G12C (12CYS) mutation result for the KRAS Mutation Status resulting from Flags/Warnings may invalidate the result for one or more individual mutation target of the kit.

Where Was This Sold?

This product was distributed to 17 states: AZ, CA, CT, FL, GA, IL, IN, MA, MN, NY, NC, OK, OR, PA, TN, TX, WV

Affected (17 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