Device recall
Z-0361-04: ARCHITECT Folate Low and Medium Controls, List 6C12-10; the kit contains 2 - 8…
FDA device recall · Class III · Abbott Laboratories HPD/ADD/GPRD
Key facts
| Recall number (Z-number) | Z-0361-04 |
|---|---|
| Recall event | 27978 |
| Product | ARCHITECT Folate Low and Medium Controls, List 6C12-10; the kit contains 2 - 8 mL vials, Low Control L 2.5 ng/mL and Medium Control M 7.0 ng/mL; 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