FDA-Device2025-04-30Class II
Beckman Coulter DxI 9000 Access Immunoassay Analyzer
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-1664-2025More Beckman Coulter, Inc. recalls
- FDA-Device2026-04-15Beckman Coulter MicroScan Neg MIC 3J antibiotic susceptibility panels recalled for manufacturing defects
- FDA-Device2026-04-15MicroScan Neg Multidrug Resistant MIC 1 REF C32368 UDI-DI code: 15099590720568 Intended Use- For use with MicroScan Dried Gram Negative MIC/Combo Panels and Dried Gram Negative Breakpoint Combo Panels. MicroScan panels are designed for use in determining antimicrobial agent susceptibility and/or identification to the species level of aerobic and facultatively anaerobic gram-negative bacilli.
- FDA-Device2026-04-01Beckman Coulter MicroScan Neg MIC 56 panels recalled for potential well contamination
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