Device recall
Z-0594-2019: Cascade Abrazo c-ACT-LR Test Card IVD FOR IN VITRO DIAGNOSTIC USE Store at 2 to…
FDA device recall · Class II · Helena Laboratories, Inc.
Key facts
| Recall number (Z-number) | Z-0594-2019 |
|---|---|
| Recall event | 81356 |
| Product | Cascade Abrazo c-ACT-LR Test Card IVD FOR IN VITRO DIAGNOSTIC USE Store at 2 to 8 C HELENA LABORATORIES 003366 12/13(2) FOR EXPORT ONLY The Cascade Abrazo c-ACT-LR test cards are activated clotting time tests to be used with the Cascade Abrazo analyzer and are intended to monitor the effect of low… |
| Product code | JPB |
| Recalling firm | Helena Laboratories, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Feb 15, 2024 |
| FEI number | 1618982 |
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