Device recall
Z-0363-04: ARCHITECT Folate Manual Diluent, List 6C12-50; One 4 mL bottle of ARCHITECT…
FDA device recall · Class III · Abbott Laboratories HPD/ADD/GPRD
Key facts
| Recall number (Z-number) | Z-0363-04 |
|---|---|
| Recall event | 27978 |
| Product | ARCHITECT Folate Manual Diluent, List 6C12-50; One 4 mL bottle of ARCHITECT Folate Manual Diluent containing TRIS buffer with protein stabilizer; Abbott Laboratories, Abbott Park, IL 60064 USA |
| Product code | CGN-- |
| Recalling firm | Abbott Laboratories HPD/ADD/GPRD |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Jul 20, 2004 |
| 510(k) numbers | K023397 |
| FEI number | 1415939 |
At a glance
- 1–9 Linked 510(k)s
- 10–99 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