Device recall
Z-1371-2025: Helix Elite" Inactivated Standard: Inactivated SARS-CoV-2 Whole Virus (Pellet)…
FDA device recall · Class II · Microbiologics Inc
Key facts
| Recall number (Z-number) | Z-1371-2025 |
|---|---|
| Recall event | 96382 |
| Product | Helix Elite" Inactivated Standard: Inactivated SARS-CoV-2 Whole Virus (Pellet), Multi-analyte, unassayed quality control material, Catalog Number HE0065N |
| Product code | OHQ |
| Recalling firm | Microbiologics Inc |
| Recall class | Class II |
| Status | Open, Classified |
| 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