Device recall
Z-2239-2008: ARCHITECT i1000SR System Assay CD ROM WW (excluding US) Special edition Version…
FDA device recall · Class II · Abbott Laboratories
Key facts
| Recall number (Z-number) | Z-2239-2008 |
|---|---|
| Recall event | 48701 |
| Product | ARCHITECT i1000SR System Assay CD ROM WW (excluding US) Special edition Version 1.01 and Version 2.0; list 01P61-01 and 01P61-02. The device is intended to duplicate manual analytical procedures by performing automatically various steps such as pipetting, preparing filtrates, heating, and measuring… |
| Product code | JJE |
| Recalling firm | Abbott Laboratories |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Mar 18, 2010 |
| FEI number | 1415939 |
At a glance
- None 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