Medical Device Recall: Beckman Coulter DxI 9000 Access Immunoassay Analyzer
Beckman Coulter, Inc. · March 27, 2025
Reason for Recall
When DxI 9000 Access Immunoassay Analyzer is connected to a host system (laboratory information system (LIS) or middleware) and has accumulated canceled QC test results that were not sent by LIS, the analyzer may lose communication with the host system. The lost connection interrupts sample processing, which delays reporting patient test results and may subsequently delay patient treatment.
Distribution
Worldwide distribution.
Quantity Affected
370 units
Source: FDA (openFDA Device Enforcement)
Recall number: Z-1664-2025
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.