Device recall
Z-1725-2015: Alkaline Wash, List number 9D31-20, a cleaning solution used by the Abbott…
FDA device recall · Class II · Abbott Laboratories
Key facts
| Recall number (Z-number) | Z-1725-2015 |
|---|---|
| Recall event | 71244 |
| Product | Alkaline Wash, List number 9D31-20, a cleaning solution used by the Abbott Architect analyzers. It is supplied in 500 mL bottles and contains NaOCl, NaOH, and KOH. It is shipped and stored at room temperature and is shipped ready to use. |
| Product code | JJE |
| Recalling firm | Abbott Laboratories |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jun 27, 2016 |
| 510(k) numbers | K980367 |
| FEI number | 1415939 |
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