Device recall
Z-0846-2012: Barbiturate Enzyme Immunoassay; R1 Antibody/Substrate Reagent (5000 tests and…
FDA device recall · Class II · Lin-Zhi International Inc
Key facts
| Recall number (Z-number) | Z-0846-2012 |
|---|---|
| Recall event | 60750 |
| Product | Barbiturate Enzyme Immunoassay; R1 Antibody/Substrate Reagent (5000 tests and 500 tests); Contains a mixture of monoclonal and polyclonal anti-barbiturate antibody, glucose 6-phosphate (G6P) and nicotinamide adenine dinucleotide (NAD), stabilizers, and with sodium azide as preservative. and… |
| Product code | DIS |
| Recalling firm | Lin-Zhi International Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jan 25, 2012 |
| 510(k) numbers | K032764 |
| 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