Drug recall
ADVIA Centaur SARS-CoV-2 Antigen Assay (100 Test Kit), SMN # 11207866
FDA recall event 88768 · Class II · Siemens Healthcare Diagnostics, Inc
Key facts
| Event ID | 88768 |
|---|---|
| Recall numbers | Z-0195-2022, Z-0196-2022 |
| Recalling firm | Siemens Healthcare Diagnostics, Inc |
| Product type | Devices |
| Products | ADVIA Centaur SARS-CoV-2 Antigen Assay (100 Test Kit), SMN # 11207866, Atellica IM SARS-CoV-2 Antigen Assay (100 Test Kit), SMN # 11207861 |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Data provided in the Emergency Use Authorization (EUA) submission was insufficient to determine that the assays were adequately validated for the intended use. |
| Initiation date | Sep 22, 2021 |
| Report date | Nov 10, 2021 |
| Termination date | Aug 2, 2022 |
| City | East Walpole |
| State | MA |
| Country | United States |
| FEI number | 1219913 |
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: