Class II — Potential Health Hazard

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

QIAGEN Rotor Gene Q Software version 2.3.4. Real-time PCR analyzer Recalled by Qiagen Sciences LLC Due to When using the Rotor-Gene Q with Software version...

Date: January 28, 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

QIAGEN Rotor Gene Q Software version 2.3.4. Real-time PCR analyzer designed for rapid thermalcycling and real-time detection of PCR assays.

Quantity: 11418 instruments

Why Was This Recalled?

When using the Rotor-Gene Q with Software version 2.3.4 completing a LIMs export, the .csv file reports the calculated concentration result value as a logarithmic value, and could lead to a false negative result, which could lead to serious medical consequences such as the suspension or non-initiation of treatment

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