Device recall
Z-0500-2026: VerifyNow PRUTest Platelet Reactivity Test REF 85225 UDI-DI code: 10711234150078…
FDA device recall · Class III · Accriva Diagnostics, Inc.
Key facts
| Recall number (Z-number) | Z-0500-2026 |
|---|---|
| Recall event | 97863 |
| Product | VerifyNow PRUTest Platelet Reactivity Test REF 85225 UDI-DI code: 10711234150078 The VerifyNow PRUTest is a whole blood test used in the laboratory or point of care setting to measure the level of platelet P2Y12 receptor blockade. |
| Product code | JOZ |
| Recalling firm | Accriva Diagnostics, Inc. |
| Recall class | Class III |
| Status | Open, Classified |
| 510(k) numbers | K141427 |
| FEI number | 2250033 |
At a glance
- 1–9 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