Device recall
Z-0838-2012: Multi-Analyte Urine DAU Control (15 mL); Level 2, For in-vitro diagnostic use…
FDA device recall · Class II · Lin-Zhi International Inc
Key facts
| Recall number (Z-number) | Z-0838-2012 |
|---|---|
| Recall event | 60691 |
| Product | Multi-Analyte Urine DAU Control (15 mL); Level 2, For in-vitro diagnostic use only. Lin-Zhi International, Inc. 670 Almanor Ave. Sunnyvale, CA 94085 Multi-Analyte Urine Drug of Drug Abuse (DAU) Controls are for use as controls in the quantitative and semi-quantitative calibration of Amphetamines… |
| Product code | DIF |
| Recalling firm | Lin-Zhi International Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jan 23, 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
- 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