Class II — Beckman Coulter, Inc.
| Recalling firm | BECKMAN COULTER, INC. |
|---|---|
| Registered facility | View this company's 22 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | 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 Paused state, leading to a delay in obtaining results. |
| Product | Beckman Coulter UniCel DxI 600, Part Numbers: A71460, A30260; Photometric Chemistry Analyzer |
| Quantity | 80 units |
| Distribution | Worldwide |
| Initiated | 2025-10-01 |
| Classified | 2025-11-04 |
| Recall number | Z-0428-2026 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Beckman Coulter, Inc. (Z-0428-2026).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/97730/
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