Medical Device Recall: DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137
Beckman Coulter, Inc. · November 13, 2024
Reason for Recall
The DxI 9000 Access Immunoassay Analyzer wash wheel mixer may not spin freely within the idler pulley housing. When the problem occurs, the analyzer may generate a system event for a Wash Wheel Dispense Arm Spin Mixer Error that is displayed on the navigation bar in the User Interface. The analyzer enters the red system status and will generate a SYS flag. The tests that are in progress may be cancelled and may cause a delay in reporting patient results
Distribution
US Nationwide. Global Distribution.
States Affected
NATIONWIDE
Quantity Affected
245 units
Source: FDA (openFDA Device Enforcement)
Recall number: Z-1326-2025
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.