Device recall
Z-0635-2021: K-ACT Actalyke Clotting Test Tubes that are used in the: ACTALYKE XL ACTIVATED…
FDA device recall · Class II · Helena Laboratories, Corp.
Key facts
| Recall number (Z-number) | Z-0635-2021 |
|---|---|
| Recall event | 86774 |
| Product | K-ACT Actalyke Clotting Test Tubes that are used in the: ACTALYKE XL ACTIVATED CLOTTING TIME ANALYZER, and ACTALYKE MINI ACTIVATED CLOTTING TIME TEST SYSTEM. |
| Product code | JPA |
| Recalling firm | Helena Laboratories, Corp. |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K013078, K061014 |
| FEI number | 1618982 |
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