Class II

Medical Device Recall: Beckman Coulter UniCel DxI 600, Part Numbers: A71460, A30260; Photometric Chemistry Analyzer

Beckman Coulter, Inc. · October 1, 2025

Reason for Recall

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.

Distribution

Worldwide

Quantity Affected

80 units

Source: FDA (openFDA Device Enforcement)

Recall number: Z-0428-2026

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.

Beckman Coulter, Inc. Medical Device Recall: Beckman Coulter UniCel DxI 600, Part Numbers: A71460, A30260; Photometric Chemistry Analyzer | SafeCheck