Device recall
Z-1626-2023: binx io CT/NG Assay- Single-use Cartridge for the qualitative detection of…
FDA device recall · Class II · Binx Health, Inc.
Key facts
| Recall number (Z-number) | Z-1626-2023 |
|---|---|
| Recall event | 92143 |
| Product | binx io CT/NG Assay- Single-use Cartridge for the qualitative detection of Chlamydia trachomatis and Neisseria gonorrhoeae Ref: 1.002.101 |
| Product code | QEP |
| Recalling firm | Binx Health, Inc. |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K200533 |
| FEI number | 3017812966 |
At a glance
- 1–9 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