Recall Z-1476-2020— Qiagen Sciences LLC
Class II · Terminated
Class II FDA medical device recall by Qiagen Sciences LLC, initiated 2020-01-28, terminated 2024-09-26. It names one FDA 510(k) clearance: K113319. 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.
- Recalling firm
- Qiagen Sciences LLC
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2020-01-28
- Terminated
- 2024-09-26
- Firm location
- Germantown, MD, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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 for recall
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
Data sourced from openFDA. This site is unofficial and independent of the FDA.