Device recall
Z-2167-2017: Liquid Urine Control Level 3 For Professional Use in the quality control…
FDA device recall · Class III · Randox Laboratories
Key facts
| Recall number (Z-number) | Z-2167-2017 |
|---|---|
| Recall event | 77152 |
| Product | Liquid Urine Control Level 3 For Professional Use in the quality control monitoring of In-Vitro Diagnostic Urinary Clinical Assays on a range of clinical chemistry systems. |
| Product code | JJY |
| Recalling firm | Randox Laboratories |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Aug 14, 2017 |
| 510(k) numbers | K110904 |
| FEI number | 3003059701 |
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