Rotor-Gene Q 2plex HRM no PC

A QIAGEN real-time PCR analyzer designed for rapid thermalcycling and real-time detection of PCR assays. The instrument carries the manufacturer's "2plex HRM" model designation and is supplied without an attached computer. It is classified by the FDA as a real-time nucleic acid amplification system (Product Code OOI) under 510(k) number K113319.

In January 2020 the manufacturer initiated a Class 2 device recall (FDA recall Z-1476-2020) covering Rotor-Gene Q instruments operating with Software version 2.3.4. When completing a LIMs export, the .csv file reported the calculated concentration result as a logarithmic value, which could lead to a false negative result. QIAGEN directed users to discontinue use of the instrument under those specific conditions and upgrade to software version 2.3.5, which resolved the issue without any other changes to the software. The recall was terminated on September 26, 2024, and the affected instruments had been distributed worldwide.