Device recall
Z-1178-2014: Cannabinoids DAU Calibrator Control Level 1 (37.5 ng/mL) This solution is…
FDA device recall · Class II · Lin-Zhi International Inc
Key facts
| Recall number (Z-number) | Z-1178-2014 |
|---|---|
| Recall event | 67521 |
| Product | Cannabinoids DAU Calibrator Control Level 1 (37.5 ng/mL) This solution is prepared from non-sterile urine and should be handled as potentially infectious. IVD; The Cannabinoids (cTHC also known as THC version c) DAU negative and positive controls are human urine-based liquids and ready to use. The… |
| Product code | DLJ |
| Recalling firm | Lin-Zhi International Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Mar 10, 2015 |
| 510(k) numbers | K021449 |
| 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