Device recall
Z-0699-2022: Helix Elite" Molecular Standards: Inactivated Standard. Inactivated Respiratory…
FDA device recall · Class II · Microbiologics Inc
Key facts
| Recall number (Z-number) | Z-0699-2022 |
|---|---|
| Recall event | 89446 |
| Product | Helix Elite" Molecular Standards: Inactivated Standard. Inactivated Respiratory Syncytial Virus A Strain Long. Target pathogens are lyophilized in a PCR compatible matrix, and stable at 2C-25C through the expiration date. Each lyophilized pellet is packaged in a single-use foil pouch. Each kit… |
| Product code | OHQ |
| Recalling firm | Microbiologics Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jan 17, 2023 |
| 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