Device recall
Z-2691-2024: DxC 500 AU Clinical Chemistry Analyzer, REF C63520 is an automated chemistry…
FDA device recall · Class II · Beckman Coulter Mishima K.K.
Key facts
| Recall number (Z-number) | Z-2691-2024 |
|---|---|
| Recall event | 95018 |
| Product | DxC 500 AU Clinical Chemistry Analyzer, REF C63520 is an automated chemistry analyzer that measures analytes in samples, in combination with appropriate reagents, calibrators, quality control (QC) material and other accessories. This system is for in vitro diagnostic use only. |
| Product code | JJE |
| Recalling firm | Beckman Coulter Mishima K.K. |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K220977 |
| FEI number | 3002807663 |
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