Class II — Potential Health Hazard

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

QIAcube Connect MDx Recalled by Qiagen Sciences LLC Due to During the "Load tip racks and enzymes" step...

Date: November 21, 2021
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

QIAcube Connect MDx, Model No. 9003070

Quantity: 93 US; 57 OUS

Why Was This Recalled?

During the "Load tip racks and enzymes" step of the run set-up, the info screen indicates "minimal volume to be loaded", but the indicated volume is instead the exact volume that should be loaded. Misunderstanding the guidance may lead to over diluted, under diluted, or improperly lysed sample, which in turn could lead to false negative or false positive results.

Where Was This Sold?

This product was distributed to 26 states: AZ, CA, CO, DE, FL, GA, IA, KS, LA, MD, MA, MN, NV, NJ, NY, NC, OH, PA, SC, SD, TN, TX, VA, WA, WI, DC

Affected (26 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