FDA Device recall Z-0784-2024
Beckman Coulter DxU 850m/840m Microscopy Analyzers, Part Numbers: C49513, C76947
- FDA Device
- Class II
- ongoing
- Published 2024-01-31
On 2024-01-31 the FDA classified a Class II recall of Beckman Coulter DxU 850m/840m Microscopy Analyzers, Part Numbers: C49513, C76947 by Beckman Coulter, citing beckman Coulter has become aware that the cannula, which is found in the Flowcell and the iQClear Rinse Waste Well Assembly, may rust. Rust from the cannula has the potential to g….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0784-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-12-19 |
| Published | 2024-01-31 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Beckman Coulter |
| Distribution | n/a |
Product
Beckman Coulter DxU 850m/840m Microscopy Analyzers, Part Numbers: C49513, C76947
Reason
Beckman Coulter has become aware that the cannula, which is found in the Flowcell and the iQClear Rinse Waste Well Assembly, may rust. Rust from the cannula has the potential to generate erroneous results.
Identifiers
| code_info | C49513, UDI/DI 15099590748647; C76947, UDI/DI 15099590748654; All serial numbers |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0784-2024%22
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