Device recall
Z-0091-2025: Cue Health COVID-19 Test Cartridge REF 2900005 Cue COVID-19 Test Cue COVID-19…
FDA device recall · Class II · CUE HEALTH INC
Key facts
| Recall number (Z-number) | Z-0091-2025 |
|---|---|
| Recall event | 95392 |
| Product | Cue Health COVID-19 Test Cartridge REF 2900005 Cue COVID-19 Test Cue COVID-19 Test for Home and Over The Counter (OTC) |
| Product code | QWB |
| Recalling firm | CUE HEALTH INC |
| Recall class | Class II |
| Status | Open, Classified |
| FEI number | 3016758165 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 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