Recall archive / FDA device enforcement
Beckman Coulter DxU 850m/840m Microscopy Analyzers, Part Numbers: C49513, C76947 — FDA record Z-0784-2024
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Dec 19, 2023. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- 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.
- Classification
- Class II
- Recalling firm
- Beckman Coulter, Inc.
- Quantity
- 254 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-0784-2024
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | C49513, UDI/DI 15099590748647; C76947, UDI/DI 15099590748654; All serial numbers |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
US and Australia, Brazil, Canada, China, France, Germany, Ghana, India, Israel, Italy, Lebanon, Lithuania, Mexico, Panama, Qatar, Romania, Saudi Arabia, Spain, Taiwan, Province of China, United Kingdom of Great Britain and Northern Ireland,
No US distribution state could be established from this record. Check the official notice.
Dates in the source
- Report date
- Jan 31, 2024
- Recall initiation date
- Dec 19, 2023
- Center classification date
- Jan 25, 2024
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.