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Beckman Coulter, Inc. recalls Beckman Coulter DxI 9000 Access Immunoassay Analyzer
Recalled April 30, 2025 · FDA recall Z-1664-2025 · Beckman Coulter
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. · FDA Class II
Units
370 units
Sold at
Worldwide distribution.
Description
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.
Product
Beckman Coulter DxI 9000 Access Immunoassay Analyzer
Manufacturer(s)
Beckman Coulter, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →