Device recall
Z-0536-2020: Platelet Aggregation Kit, Cat. No.5369, For use in platelet aggregation studies…
FDA device recall · Class III · Helena Laboratories, Corp.
Key facts
| Recall number (Z-number) | Z-0536-2020 |
|---|---|
| Recall event | 83930 |
| Product | Platelet Aggregation Kit, Cat. No.5369, For use in platelet aggregation studies, Contains: 2X1 mL ADP Reagent containing adenosine diphosphate, 2X 1 mL Collagen Reagent containing collagen (equine tendon), 2 x 1 mL Epinephrine Reagent containing L-epinephrine, FOR IN-VITRO DIAGNOSTIC USE, Store at 2… |
| Product code | GHR |
| Recalling firm | Helena Laboratories, Corp. |
| Recall class | Class III |
| Status | Open, Classified |
| 510(k) numbers | K910706 |
| FEI number | 1618982 |
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