Drug recall
Beckman Coulter DxU 850m/840m Microscopy Analyzers, Part Numbers: C49513, C76947
FDA recall event 93655 · Class II · Beckman Coulter, Inc.
Key facts
| Event ID | 93655 |
|---|---|
| Recall numbers | Z-0784-2024, Z-0785-2024, Z-0786-2024, Z-0787-2024 |
| Recalling firm | Beckman Coulter, Inc. |
| Product type | Devices |
| Products | Beckman Coulter DxU 850m/840m Microscopy Analyzers, Part Numbers: C49513, C76947, iQ200 Series Urine Microscopy Analyzers, Part Numbers: a) 700-3320, b) 700-3370, c) 700-3345, d) 700-3347, e) C10683, f) 700-3375, g) 700-3325, h) C10684, iQ Waste Well Adapter, Part Number: 700-3393, REV 2 Flowcell Capsule Spare, Part Number: C04154 |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | 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… |
| Initiation date | Dec 19, 2023 |
| Report date | Jan 31, 2024 |
| City | Miami |
| State | FL |
| Country | United States |
| FEI number | 3000203293 |
At a glance
- 1–9 Products in this recall
- 1–9 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: