Beckman Coulter recalled 571 DxI 9000 Access Immunoassay Analyzers on September 19, 2025, due to a software anomaly. The defect may lead to inaccurate patient test results affecting diagnoses. Healthcare providers must stop using the device immediately and follow recall instructions.
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.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Beckman Coulter, Inc. or your healthcare provider for instructions. Notification method: Letter
The recall affects the DxI 9000 Access Immunoassay Analyzer, Part Number C11137. This product has been distributed worldwide. It has a quantity of 571 units.
A software issue on the DxI 9000 may prevent correct application of user-specified manual dilution factors. This anomaly could result in false low or high patient results, leading to possible misdiagnoses.
No specific incidents were detailed in the recall announcement. However, the risk of erroneous diagnoses due to false test results poses a significant concern.
Patients and healthcare providers should stop using the DxI 9000 Access Immunoassay Analyzer immediately. For instructions, contact Beckman Coulter or your healthcare provider.
For more information, call Beckman Coulter at 1-800-999-9499 or visit their website at www.beckmancoulter.com.
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