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 | Ground screws on Dxl 9000 PCB boards may cause electric shorts, leading to smoke and potentially delaying patient results. Smoke also poses a hazard to equipment and users. |
| Product | DxI 9000 Access Immunoassay Analyzer, catalog number C11137 in vitro diagnostic device used for the quantitative, semi-quantitative, or qualitative determination of various analyte concentrations found in human body fluids |
| Quantity | 30 OUS |
| Distribution | OUS (Foreign) distribution to countries of: Australia, Croatia, Czechia, France, Germany, Ireland, Israel, Italy, Netherlands, New Zealand, South Africa, Spain, and United Kingdom of Great Britain and Northern Ireland. |
| Initiated | 2024-07-12 |
| Classified | 2025-04-04 |
| Recall number | Z-1529-2025 |
| 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-1529-2025).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/96406/
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