FDA-Device2025-11-12Class IIPROCESSING DEFECT
Beckman Coulter UniCel DxI 800, Part Numbers: 973100, A71456; Photometric Chemistry Analyzer
Hazard
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.
Intended for
All ages
Illnesses reported
None reported
Sold states
Worldwide
Affected count
657 units
Manufactured in
1000 Lake Hazeltine Dr, N/A, Chaska, MN, United States
Products
Beckman Coulter UniCel DxI 800, Part Numbers: 973100, A71456; Photometric Chemistry Analyzer
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0429-2026Want us to check the next one for you?
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