Device recall
Z-2325-2009: ARCHITECT i System Assay CD ROM - US, list 6E58-22, Version 22.01, and ARCHITECT…
FDA device recall · Class III · Abbott Laboratories
Key facts
| Recall number (Z-number) | Z-2325-2009 |
|---|---|
| Recall event | 51928 |
| Product | ARCHITECT i System Assay CD ROM - US, list 6E58-22, Version 22.01, and ARCHITECT i System Assay CD-ROM - WW (excluding US), list 6E59-23, Version 23.0, containing the ARCHITECT LH assay file; Abbott Laboratories, Diagnostic Division, Abbott Park, IL 60064 USA; Product List Number: 6E58 (US) and 6E59… |
| Product code | JJE |
| Recalling firm | Abbott Laboratories |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Nov 30, 2009 |
| 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