Device recall
Z-0537-2020: Collagen Reagent, Cat. No. 5368, 2 X 1 mL, For use in platelet aggregation…
FDA device recall · Class III · Helena Laboratories, Corp.
Key facts
| Recall number (Z-number) | Z-0537-2020 |
|---|---|
| Recall event | 83930 |
| Product | Collagen Reagent, Cat. No. 5368, 2 X 1 mL, For use in platelet aggregation studies, Contains: Collagen (equine tendon) For In-Vitro Diagnostic Use, |
| 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