Device recall
Z-1576-2016: Drew Scientific Inc. Drew3-PAC. This D3 Reagent Pack includes: diluent reagent…
FDA device recall · Class II · Jas Diagnostics/Drew Scientific
Key facts
| Recall number (Z-number) | Z-1576-2016 |
|---|---|
| Recall event | 73650 |
| Product | Drew Scientific Inc. Drew3-PAC. This D3 Reagent Pack includes: diluent reagent 5L, enzymatic cleaner 750 mL, and a lysing reagent 125 mL. |
| Product code | GKZ |
| Recalling firm | Jas Diagnostics/Drew Scientific |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 21, 2019 |
| 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