FDA Device recall Z-1476-2020
QIAGEN Rotor Gene Q Software version 2.3.4. Real-time PCR analyzer designed for rapid thermalcycling and real-time detection of PCR assays
- FDA Device
- Class II
- terminated
- Published 2020-03-18
On 2020-03-18 the FDA classified a Class II recall of QIAGEN Rotor Gene Q Software version 2.3.4. Real-time PCR analyzer designed for rapid thermalcycling and real-time detection of PCR assays by Qiagen Sciences, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1476-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-01-28 |
| Published | 2020-03-18 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Qiagen Sciences |
| Distribution | US |
Product
QIAGEN Rotor Gene Q Software version 2.3.4. Real-time PCR analyzer designed for rapid thermalcycling and real-time detection of PCR assays.
Reason
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
Identifiers
| code_info | Software version 2.3.4 used in the following: Product No. / Description 9001680 Rotor-Gene Q 2Plex no PC 9001680R R…Software version 2.3.4 used in the following: Product No. / Description 9001680 Rotor-Gene Q 2Plex no PC 9001680R Rotor-Gene Q 2Plex no PC refurbished 9001690 Rotor-Gene Q 2Plex HRM no PC 9001690R Rotor-Gene Q 2Plex HRM no PC refurbished 9001700 Rotor-Gene Q 5Plex no PC 9001700R Rotor-Gene Q 5Plex no PC refurbished 9001710 Rotor-Gene Q 5Plex HRM no PC 9001710R Rotor-Gene Q 5Plex HRM no PC refurbished 9001720 Rotor-Gene Q 6Plex no PC 9001720R Rotor-Gene Q 6Plex no PC refurbished 9001960 Rotor-Gene AusDx (Outback Red) 9002000 Rotor-Gene Q MDx 2Plex 9002001 Rotor-Gene Q MDx 2Plex no PC 9002010 Rotor-Gene Q MDx 2Plex HRM 9002011 #Rotor-Gene Q MDx 2Plex HRM no PC 9002020 Rotor-Gene Q MDx 5Plex 9002021 Rotor-Gene Q MDx 5Plex no PC 9002029 Rotor-Gene Q MDx 5plex, PrioPLUS 9002030 Rotor-Gene Q MDx 5Plex HRM 9002030R Rotor-Gene Q MDx 5Plex HRM refurbished 9002031 Rotor-Gene Q MDx 5Plex HRM no PC 9002040 Rotor-Gene Q MDx 6Plex 9002041 Rotor-Gene Q MDx 6Plex no PC90275010 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1476-2020%22
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