Device recall
Z-0386-2014: Single Analyte Urine DAU Control (5 m L Norbuprenorphine, Level II control For…
FDA device recall · Class III · Lin-Zhi International Inc
Key facts
| Recall number (Z-number) | Z-0386-2014 |
|---|---|
| Recall event | 66542 |
| Product | Single Analyte Urine DAU Control (5 m L Norbuprenorphine, Level II control For In Vitro Diagnostic Use Only. store at 2 - 8 degrees C. Contents: Contains 13 mg/Ml of Norbuprenorphine in human urine with sodium azide as a preservative. Manufacturer: Lin-Zhi International, Inc. 670 Almanor Ave… |
| Product code | LAS |
| Recalling firm | Lin-Zhi International Inc |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Dec 26, 2013 |
| 510(k) numbers | K081008 |
| FEI number | 3003610499 |
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