FDA-Device2025-10-29Class II
DxI 9000 Access Immunoassay Analyzer, Part Number C11137
Beckman Coulter, Inc.
Hazard
Beckman Coulter has confirmed a software anomaly on DxI 9000 Access Immunoassay Analyzer and the DxC 500i Clinical Analyzer that may prevent correct application of user-specified manual dilution factors when ordering additional tests for samples already "In Progress" using the same "Sample ID number". This can lead to false low or high patient results and potential delays in reporting, risking erroneous diagnoses if undetected.
Sold states
Worldwide - US Nationwide distribution.
Affected count
571 units
Manufactured in
1000 Lake Hazeltine Dr, Chaska, MN, United States
Products
DxI 9000 Access Immunoassay Analyzer, Part Number C11137
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0216-2026Don't want to check this manually?
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