Drug recall
SARS-CoV-2 Antigen Test
FDA recall event 87205 · Class II · Qiagen Sciences LLC
Key facts
| Event ID | 87205 |
|---|---|
| Recall numbers | Z-0941-2021 |
| Recalling firm | Qiagen Sciences LLC |
| Product type | Devices |
| Products | SARS-CoV-2 Antigen Test |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | QIAGEN has become aware of the potential for false positive results to occur with some patient samples. |
| Initiation date | Jan 15, 2021 |
| Report date | Feb 10, 2021 |
| Termination date | Jul 11, 2022 |
| 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: