Drug recall
QIAGEN Rotor Gene Q Software version 2.3.4. Real-time PCR analyzer designed for rapid thermalcycling and…
FDA recall event 85004 · Class II · Qiagen Sciences LLC
Key facts
| Event ID | 85004 |
|---|---|
| Recall numbers | Z-1476-2020 |
| Recalling firm | Qiagen Sciences LLC |
| Product type | Devices |
| 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. |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| 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… |
| Initiation date | Jan 28, 2020 |
| Report date | Mar 18, 2020 |
| Termination date | Sep 26, 2024 |
| City | Germantown |
| State | MD |
| Country | United States |
| FEI number | 3003572099 |
At a glance
- 1–9 Products in this recall
- 10–99 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: