Device recall
Z-2407-2020: Utak NR Trace Elements Serum Control, 5 ml, REF 66816. The responsible firm on…
FDA device recall · Class III · Utak Laboratories Inc
Key facts
| Recall number (Z-number) | Z-2407-2020 |
|---|---|
| Recall event | 85660 |
| Product | Utak NR Trace Elements Serum Control, 5 ml, REF 66816. The responsible firm on the label is UTAK LABORATORIES, INC., Valencia, CA. Control for in vitro diagnostics. |
| Product code | JJY |
| Recalling firm | Utak Laboratories Inc |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Jul 22, 2020 |
| 510(k) numbers | K883147 |
| FEI number | 2022375 |
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