Device recall
Z-0032-2026: DxC 500 AU Module w/ISE, DxC 500i, With ISE, REF: C63522 and DxC 500 AU Module…
FDA device recall · Class II · Beckman Coulter Inc.
Key facts
| Recall number (Z-number) | Z-0032-2026 |
|---|---|
| Recall event | 97390 |
| Product | DxC 500 AU Module w/ISE, DxC 500i, With ISE, REF: C63522 and DxC 500 AU Module, DxC 500i, Without ISE, REF: C6352; part of the DxC 500i Clinical Analyzer |
| Product code | CGR |
| Recalling firm | Beckman Coulter Inc. |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K242190 |
| FEI number | 2050012 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 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