Device recall
Z-2150-2019: Human Assayed Multi-Sera Level 2, Model NO. HN1530 Product Usage: This product…
FDA device recall · Class II · Randox Laboratories, Limited
Key facts
| Recall number (Z-number) | Z-2150-2019 |
|---|---|
| Recall event | 83155 |
| Product | Human Assayed Multi-Sera Level 2, Model NO. HN1530 Product Usage: This product is intended for in vitro diagnostic use, in the quality control of diagnostic assays. The Human Assayed Multi-sera is for the control of accuracy. |
| Product code | JJY |
| Recalling firm | Randox Laboratories, Limited |
| Recall class | Class II |
| Status | Terminated |
| Termination date | May 15, 2020 |
| 510(k) numbers | K942458 |
| FEI number | 1000361607 |
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