Device recall
Z-0847-2012: Multi-Analyte Urine DAU Calibrator (15 mL); Multi-Analyte,Intermediate…
FDA device recall · Class II · Lin-Zhi International Inc
Key facts
| Recall number (Z-number) | Z-0847-2012 |
|---|---|
| Recall event | 60757 |
| Product | Multi-Analyte Urine DAU Calibrator (15 mL); Multi-Analyte,Intermediate Calibrator; for in-vitro diagnostic use only. Contains 300 ng/mL benzoylecgonine, 750 ng/mL d-methamphetamine, 4000 ng/m: morphine, 50 phencyclidine, 500 ng/m: oxazepam, 500 ng/mL secobarbital, 700ng/mL propoxyphene and 600 ng.mL… |
| 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