Recall archive / FDA device enforcement
UA WIN 10 Kit, Catalog Number C52900, in-vitro diagnostic device, urine analysis — FDA record Z-1599-2023
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 Apr 5, 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
- UA WIN 10 Kit, Catalog Number C52900, in-vitro diagnostic device, urine analysis
- Reason
- Beckman Coulter has become aware of an intermittent issue in which the optional flag "Previous Sample Had Sperm" was enabled but not displayed so that a carryover event could have been investigated.
- Classification
- Class II
- Recalling firm
- Beckman Coulter, Inc.
- Quantity
- 306 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-1599-2023
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 | UDI/DI 15099590735982, All analyzers with Windows 10, Software Versions 8.5, 8.5.1 and 8.6 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
Worldwide Distribution
No US distribution state could be established from this record. Check the official notice.
Dates in the source
- Report date
- May 24, 2023
- Recall initiation date
- Apr 5, 2023
- Center classification date
- May 17, 2023
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.