Device recall
Z-0958-2007: IMx Theophylline Reagent Pack (List 1A81-20) In Vitro test. This reagent system…
FDA device recall · Class II · Abbott Diagnostic International, Ltd.
Key facts
| Recall number (Z-number) | Z-0958-2007 |
|---|---|
| Recall event | 37957 |
| Product | IMx Theophylline Reagent Pack (List 1A81-20) In Vitro test. This reagent system is composed of one bottle of Theophylline Pretreatment Solution, one bottle of Theophylline Antiserum (Mouse Monoclonal) and one bottle of Theophylline Fluorescein Tracer. |
| Product code | LER |
| Recalling firm | Abbott Diagnostic International, Ltd. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jun 10, 2011 |
| 510(k) numbers | K833070 |
| FEI number | 2623532 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 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