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Beckman Coulter, Inc. recalls DxI 9000 Access Immunoassay Analyzer, Part Number C11137
Recalled October 29, 2025 · FDA recall Z-0216-2026 · Beckman Coulter
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. · FDA Class II
Units
571 units
Sold at
Worldwide - US Nationwide distribution.
Description
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.
Product
DxI 9000 Access Immunoassay Analyzer, Part Number C11137
Manufacturer(s)
Beckman Coulter, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →