Device recall
Z-1233-2025: DxC 500 AU Clinical Chemistry Analyzer, REF: C63519, and C63520 with affected…
FDA device recall · Class II · BECKMAN COULTER LABORATORY SYSTEMS (SUZHOU) CO., LTD.
Key facts
| Recall number (Z-number) | Z-1233-2025 |
|---|---|
| Recall event | 96193 |
| Product | DxC 500 AU Clinical Chemistry Analyzer, REF: C63519, and C63520 with affected software. |
| Product code | JJE |
| Recalling firm | BECKMAN COULTER LABORATORY SYSTEMS (SUZHOU) CO., LTD. |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K220977 |
| FEI number | 3027977508 |
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