Device recall
Z-0413-2007: ARCHITECT i System Assay CD-ROM, in vitro diagnostic analyzer, U.S. Version…
FDA device recall · Class III · Abbott Laboratories MPG
Key facts
| Recall number (Z-number) | Z-0413-2007 |
|---|---|
| Recall event | 37070 |
| Product | ARCHITECT i System Assay CD-ROM, in vitro diagnostic analyzer, U.S. Version 21.0; for use on the ARCHITECT i System; Abbott Laboratories, Abbott Park, IL 60064; list number 06E58-21 |
| Product code | JJI |
| Recalling firm | Abbott Laboratories MPG |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Dec 9, 2009 |
| PMA numbers | P050042, P050051 |
| FEI number | 1415939 |
At a glance
- None 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