Device recall
Z-0827-2015: Glucose Hexokinase (Liquid) Reagent For the in vitro quantitative determination…
FDA device recall · Class II · JAS Diagnostics Inc.
Key facts
| Recall number (Z-number) | Z-0827-2015 |
|---|---|
| Recall event | 69622 |
| Product | Glucose Hexokinase (Liquid) Reagent For the in vitro quantitative determination of Glucose in serum. |
| Product code | CFR |
| Recalling firm | JAS Diagnostics Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Feb 26, 2015 |
| 510(k) numbers | K011900 |
| FEI number | 3003071743 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 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