Device recall
Z-3184-2024: BinaxNOW Respiratory Strep A Test Kit, CLIA Waived, Catalog Number 730025
FDA device recall · Class II · Cypress Medical Products LLC
Key facts
| Recall number (Z-number) | Z-3184-2024 |
|---|---|
| Recall event | 95235 |
| Product | BinaxNOW Respiratory Strep A Test Kit, CLIA Waived, Catalog Number 730025 |
| Product code | GTZ |
| Recalling firm | Cypress Medical Products LLC |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K012521 |
| FEI number | 1451040 |
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