Drug recall
Beckman Coulter UniCel DxI 600, Part Numbers: A71460, A30260; Photometric Chemistry Analyzer
FDA recall event 97730 · Class II · Beckman Coulter, Inc.
Key facts
| Event ID | 97730 |
|---|---|
| Recall numbers | Z-0428-2026, Z-0429-2026 |
| Recalling firm | Beckman Coulter, Inc. |
| Product type | Devices |
| Products | Beckman Coulter UniCel DxI 600, Part Numbers: A71460, A30260; Photometric Chemistry Analyzer, Beckman Coulter UniCel DxI 800, Part Numbers: 973100, A71456; Photometric Chemistry Analyzer |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | An internal investigation has determined that due to defective sub-components within the gantry assembly, a z-axis CAD movement motion error may occur and cause an analyzer to enter a Not Ready or… |
| Initiation date | Oct 1, 2025 |
| Report date | Nov 12, 2025 |
| City | Chaska |
| State | MN |
| Country | United States |
| FEI number | 2122870 |
At a glance
- 1–9 Products in this recall
- 10–99 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: