Recall archive / FDA device enforcement
Beckman Coulter DxI 9000 Access Immunoassay Analyzer — FDA record Z-1664-2025
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 Mar 27, 2025. 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 DxI 9000 Access Immunoassay Analyzer
- Reason
- When DxI 9000 Access Immunoassay Analyzer is connected to a host system (laboratory information system (LIS) or middleware) and has accumulated canceled QC test results that were not sent by LIS, the analyzer may lose communication with the host system. The lost connection interrupts sample processing, which delays reporting patient test results and may subsequently delay patient treatment.
- Classification
- Class II
- Recalling firm
- Beckman Coulter, Inc.
- Quantity
- 370 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-1664-2025
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 15099590732103, all units run with system software versions SW 1.20.0 and below |
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
- Apr 30, 2025
- Recall initiation date
- Mar 27, 2025
- Center classification date
- Apr 24, 2025
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.