Drug recall
Helix Elite Inactivated Standard, labeled as: a. Inactivated SARS-CoV-2 B.1.1.7 Whole Virus, REF HE0071N; b…
FDA recall event 90761 · Class III · Microbiologics Inc
Key facts
| Event ID | 90761 |
|---|---|
| Recall numbers | Z-1740-2022 |
| Recalling firm | Microbiologics Inc |
| Product type | Devices |
| Products | Helix Elite Inactivated Standard, labeled as: a. Inactivated SARS-CoV-2 B.1.1.7 Whole Virus, REF HE0071N; b. Inactivated SARS-CoV-2 B.1.351 Whole Virus, REF HE0073N |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Product not registered for use in the UK |
| Initiation date | Jul 27, 2022 |
| Report date | Sep 21, 2022 |
| Termination date | Aug 2, 2024 |
| City | Saint Cloud |
| State | MN |
| Country | United States |
| FEI number | 2150138 |
At a glance
- 1–9 Products in this recall
- 1–9 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: