Device recall
Z-1108-2021: Cascade Abrazo aPTT Test Card - Product Usage: are to be used with the Cascade…
FDA device recall · Class II · Helena Laboratories, Corp.
Key facts
| Recall number (Z-number) | Z-1108-2021 |
|---|---|
| Recall event | 87151 |
| Product | Cascade Abrazo aPTT Test Card - Product Usage: are to be used with the Cascade Abrazo analyzer and are intended for the determination of the activated Partial Thromboplastin Time (aPTT) of citrated whole blood or plasma, Model 5722, For Export Only. |
| Product code | GFO |
| Recalling firm | Helena Laboratories, Corp. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Nov 19, 2024 |
| FEI number | 1618982 |
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