Drug recall
QIAstat-Dx Respiratory SARS-CoV-2 Panel multiplexed nucleic acid real-time PCR test, Reference Number 691223
FDA recall event 92298 · Class II · Qiagen Sciences LLC
Key facts
| Event ID | 92298 |
|---|---|
| Recall numbers | Z-1683-2023 |
| Recalling firm | Qiagen Sciences LLC |
| Product type | Devices |
| Products | QIAstat-Dx Respiratory SARS-CoV-2 Panel multiplexed nucleic acid real-time PCR test, Reference Number 691223 |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Faulty cartridges in the lot could result in false test results. |
| Initiation date | Apr 28, 2023 |
| Report date | Jun 14, 2023 |
| 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: