Device recall
Z-2317-2009: AxSYM System Tubing Decontamination Solution; 500 mL bottle; Abbott…
FDA device recall · Class III · Abbott Laboratories
Key facts
| Recall number (Z-number) | Z-2317-2009 |
|---|---|
| Recall event | 51258 |
| Product | AxSYM System Tubing Decontamination Solution; 500 mL bottle; Abbott Laboratories, Diagnostics Division, Abbott Park, IL 60064; List Number 07B05-09. To be used only for cleaning and inhibition of fouling bacteria in the tubing system of the in vitro immunoassay analyzer. This product does not… |
| Product code | JJE |
| Recalling firm | Abbott Laboratories |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Jul 8, 2010 |
| 510(k) numbers | K974651 |
| 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