Device recall
Z-0868-2012: Multi-Analyte Urine DAU Calibrator (15 mL HDPE bottle inside a cardboard box)…
FDA device recall · Class II · Lin-Zhi International Inc
Key facts
| Recall number (Z-number) | Z-0868-2012 |
|---|---|
| Recall event | 60743 |
| Product | Multi-Analyte Urine DAU Calibrator (15 mL HDPE bottle inside a cardboard box) For in vitro diagnostic use only. Lin-Zhi International, Inc.. 670 Almanor Ave. Sunnyvale, CA 94085 intended use: Drug abuse detection. |
| Product code | DKB |
| Recalling firm | Lin-Zhi International Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jan 25, 2012 |
| 510(k) numbers | K051088 |
| 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