Medical Device Recall: DxI 9000 Access Immunoassay Analyzer, Part Number C11137
Beckman Coulter, Inc. · September 19, 2025
Reason for Recall
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.
Distribution
Worldwide - US Nationwide distribution.
States Affected
NATIONWIDE
Quantity Affected
571 units
Source: FDA (openFDA Device Enforcement)
Recall number: Z-0216-2026
Status: ongoing
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