Device recall
Z-1740-2022: Helix Elite Inactivated Standard, labeled as: a. Inactivated SARS-CoV-2 B.1.1.7…
FDA device recall · Class III · Microbiologics Inc
Key facts
| Recall number (Z-number) | Z-1740-2022 |
|---|---|
| Recall event | 90761 |
| Product | 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 |
| Product code | OHQ |
| Recalling firm | Microbiologics Inc |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Aug 2, 2024 |
| FEI number | 2150138 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database