Device recall
Z-0299-2008: ARCHITECT i System Assay CD-ROM - WW (excluding USA accounts), Versions prior to…
FDA device recall · Class II · Abbott Laboratories
Key facts
| Recall number (Z-number) | Z-0299-2008 |
|---|---|
| Recall event | 45397 |
| Product | ARCHITECT i System Assay CD-ROM - WW (excluding USA accounts), Versions prior to Version 24.0; for use on the ARCHITECT i System; List Number (LN) 6E59,Abbott Laboratories, Diagnostics Division, Abbott Park, IL 60064 USA |
| Product code | LOJ |
| Recalling firm | Abbott Laboratories |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Nov 5, 2008 |
| PMA numbers | P820060 |
| 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