Medical Device Recall: Beckman Coulter DxI 9000 Access Immunoassay Analyzer, catalog number C11137; in-vitro diagnostic instrument
Beckman Coulter, Inc. · January 3, 2024
Reason for Recall
A software error caused an increase in tray gripper motion errors that causes intermittent hard stops and a delay in patient results.
Distribution
Worldwide distribution - US Nationwide and the countries of Australia, Austria, Brazil, Croatia, France, Germany, Hungary, India, Ireland, Italy, New Zealand, Portugal, Slovakia, Spain, Switzerland, Taiwan, Province of China, United Kingdom of Great Britain and Northern Ireland.
States Affected
NATIONWIDE
Quantity Affected
61 units
Source: FDA (openFDA Device Enforcement)
Recall number: Z-1115-2025
Status: completed
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.