Device recall
Z-2973-2026: Beckman Coulter DxC 500i Clinical Analyzer Modules using software version 1.5 or…
FDA device recall · Class II · Beckman Coulter Inc.
Key facts
| Recall number (Z-number) | Z-2973-2026 |
|---|---|
| Recall event | 99436 |
| Product | Beckman Coulter DxC 500i Clinical Analyzer Modules using software version 1.5 or lower: 1) DxC 500 AU Module w/ISE, DxC 500i, Part Number C63522; 2) DxC 500 AU Module, DxC 500i, Part Number C63521; 3) Access 2 Module, DxC 500i, Part Number C13252; DxC 500 AU Clinical Chemistry Analyzers |
| Product code | JJE |
| 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
- 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