Device recall
Z-1270-2014: Single Analyte DAU Calibrator (5 mL) Norbuprenorphine: Cutoff Calibrator; IVD…
FDA device recall · Class III · Lin-Zhi International Inc
Key facts
| Recall number (Z-number) | Z-1270-2014 |
|---|---|
| Recall event | 67607 |
| Product | Single Analyte DAU Calibrator (5 mL) Norbuprenorphine: Cutoff Calibrator; IVD - for in vitro diagnostic use only; Lin-Zhi International Sunnyvale, CA The Norbuprenorphine Drug of Abuse (DAU) cutoff Calibrator is used for qualitative and semi-qualitative calibration of the Lin-Zhi Internal, Inc… |
| Product code | DJG |
| Recalling firm | Lin-Zhi International Inc |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Apr 25, 2014 |
| 510(k) numbers | K081008 |
| FEI number | 3003610499 |
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