Device recall
Z-0272-2022: ARCHITECT c4000 REF 02P24-01/2P24, 1P86, 1R24, and 1R25; ARCHITECT c8000 REF…
FDA device recall · Class II · Abbott Laboratories
Key facts
| Recall number (Z-number) | Z-0272-2022 |
|---|---|
| Recall event | 88880 |
| Product | ARCHITECT c4000 REF 02P24-01/2P24, 1P86, 1R24, and 1R25; ARCHITECT c8000 REF 01G06-11/1G06; ARCHITECT c16000 REF 03L77-01/3L77; |
| Product code | JJE |
| Recalling firm | Abbott Laboratories |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K983212 |
| FEI number | 3016438761 |
At a glance
- 1–9 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