Device recall
Z-0781-04: ARCHITECT CA 19-9 Reagent Kit, list 6C04-20 (1 x 100 tests) and 6C04-25 (4 x 100…
FDA device recall · Class II · Abbott Laboratories HPD/ADD/GPRD
Key facts
| Recall number (Z-number) | Z-0781-04 |
|---|---|
| Recall event | 28641 |
| Product | ARCHITECT CA 19-9 Reagent Kit, list 6C04-20 (1 x 100 tests) and 6C04-25 (4 x 100 tests), Abbott laboratories, Abbott Park, IL 60064 U.S.A. |
| Product code | NIG |
| Recalling firm | Abbott Laboratories HPD/ADD/GPRD |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 26, 2005 |
| FEI number | 1415939 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 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