Device recall
Z-1256-2019: Ethyl Alcohol Enzymatic Assay, (a) REF 0220 (small test kit), (b) REF 0221…
FDA device recall · Class III · Lin-Zhi International Inc
Key facts
| Recall number (Z-number) | Z-1256-2019 |
|---|---|
| Recall event | 82011 |
| Product | Ethyl Alcohol Enzymatic Assay, (a) REF 0220 (small test kit), (b) REF 0221 (large test kit) Product Usage: Detergent causes faster degradation in EtOH assay. Possible container or pitchers with some detergent residue was used while producing R2 of the defective lot. |
| Product code | DIC |
| Recalling firm | Lin-Zhi International Inc |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Mar 22, 2021 |
| 510(k) numbers | K032461 |
| 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