Class II
Medical Device Recall: DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137.
Beckman Coulter, Inc. · February 5, 2025
Reason for Recall
the DxI 9000 encoder wheel was misaligned on the motor shaft, leading to increased slippage errors and causing the instrument to stop, posing a high safety risk due to potential delays in patient results.
Distribution
US Nationwide. Global Distribution.
States Affected
NATIONWIDE
Quantity Affected
206 units
Source: FDA (openFDA Device Enforcement)
Recall number: Z-1388-2025
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.