Device recall
Z-0293-04: IMx Folate Reagent Pack, list 2220-88 (100 tests - reagents packaged with Ion…
FDA device recall · Class II · Abbott Laboratories HPD/ADD/GPRD
Key facts
| Recall number (Z-number) | Z-0293-04 |
|---|---|
| Recall event | 27835 |
| Product | IMx Folate Reagent Pack, list 2220-88 (100 tests - reagents packaged with Ion Capture Reaction Cells) and list 2220-20 (100 tests - reagents alone); Abbott Laboratories, Abbott Park, IL 60064 USA |
| Product code | CGN-- |
| Recalling firm | Abbott Laboratories HPD/ADD/GPRD |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jul 22, 2004 |
| 510(k) numbers | K9436912 |
| FEI number | 1415939 |
At a glance
- 1–9 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