Class II — Potential Health Hazard

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

Brand Name: QIAstat-Dx Product Name: QIAstat-Dx Respiratory Panel Plus Reference Recalled by Qiagen Sciences LLC Due to Identified faulty cartridges. If such a faulty cartridge...

Date: March 12, 2025
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

Brand Name: QIAstat-Dx Product Name: QIAstat-Dx Respiratory Panel Plus Reference Number (REF): 691224 Software Version: n/a Component: n/a

Quantity: 445 units

Why Was This Recalled?

Identified faulty cartridges. If such a faulty cartridge is used for sample testing, false test results could occur.

Where Was This Sold?

This product was distributed to 12 states: AL, CA, FL, IN, KS, KY, ME, MA, MN, NY, TX, DC

Affected (12 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