FDA-Device2025-04-30Class II
Beckman Coulter DxI 9000 Access Immunoassay Analyzer
Beckman Coulter, Inc.
Hazard
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.
Sold states
Worldwide distribution.
Affected count
370 units
Manufactured in
1000 Lake Hazeltine Dr, N/A, Chaska, MN, United States
Products
Beckman Coulter DxI 9000 Access Immunoassay Analyzer
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1664-2025Don't want to check this manually?
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