Device recall
Z-2656-2017: Drew Scientific DREW 3-PAC Reagent Kit containing: 5L Diluent, 750 mL Enzymatic…
FDA device recall · Class II · JAS Diagnostics Inc.
Key facts
| Recall number (Z-number) | Z-2656-2017 |
|---|---|
| Recall event | 77464 |
| Product | Drew Scientific DREW 3-PAC Reagent Kit containing: 5L Diluent, 750 mL Enzymatic Cleaner, and 125 mL Lysing Reagent. |
| Product code | GKZ |
| Recalling firm | JAS Diagnostics Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jan 6, 2020 |
| 510(k) numbers | K071562 |
| FEI number | 3003071743 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 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