Device recall
Z-2923-2020: Amylase AY3805 batch 480449 Amylase Ethylidene Blocked-pNPG7 Reagent
FDA device recall · Class II · RANDOX LABORATORIES, LTD.
Key facts
| Recall number (Z-number) | Z-2923-2020 |
|---|---|
| Recall event | 86114 |
| Product | Amylase AY3805 batch 480449 Amylase Ethylidene Blocked-pNPG7 Reagent |
| Product code | CIJ |
| Recalling firm | RANDOX LABORATORIES, LTD. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jun 17, 2021 |
| 510(k) numbers | K953211 |
| FEI number | 3006697287 |
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