Recall archive / FDA device enforcement
Beckman Coulter UniCel DxI 600, Part Numbers: A71460, A30260; Photometric Chemistry Analyzer — FDA record Z-0428-2026
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 Oct 1, 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 UniCel DxI 600, Part Numbers: A71460, A30260; Photometric Chemistry Analyzer
- Reason
- An internal investigation has determined that due to defective sub-components within the gantry assembly, a z-axis CAD movement motion error may occur and cause an analyzer to enter a Not Ready or Paused state, leading to a delay in obtaining results.
- Classification
- Class II
- Recalling firm
- Beckman Coulter, Inc.
- Quantity
- 80 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-0428-2026
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 | A71460, UDI/DI 15099590369224, Serial Numbers: 902515, 902529, 902528, 902534, 902526, 902527, 902523, 902522, 902524, 902505, 902578, 902579, 902545, 902530, 902531, 902581, 902504, 902514, 902525, 902535, 902566, 902516, 902518, 902532, 902555, 902558, 902564, 902519, 902521, 902559, 902511, 902549, 902554, 902547, 902582, 902583; A30260, UDI/DI 15099590341602, Serial Numbers: 902536, 902541, 902517, 902563, 902565, 902557, 902513, 902507, 902543, 902560, 902562, 902506, 902508, 902574, 902533, 902572, 902540, 902569, 902568, 902577, 902510, 902580, 902567, 902573, 902570, 902571, 902538, 902553, 902552, 902512, 902539, 902561, 902575, 902544, 902542, 902556, 902537, 902509, 902520, 902546, 902548, 902551, 902550, 902576. |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
Worldwide
No US distribution state could be established from this record. Check the official notice.
Dates in the source
- Report date
- Nov 12, 2025
- Recall initiation date
- Oct 1, 2025
- Center classification date
- Nov 4, 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.