Beckman Coulter recalled 160 DxC 500i Clinical Analyzer modules on September 19, 2025. A software anomaly may cause incorrect manual dilution factors, leading to false patient results. Healthcare providers must stop using the devices immediately to avoid erroneous diagnoses.
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 includes the DxC 500i Clinical Analyzer Modules, DxC 500 AU Module w/ISE, and Access 2 Module. The affected part numbers are C63522, C63521, and C13252. These devices were distributed worldwide.
The software anomaly may prevent correct application of user-specified manual dilution factors. This issue can lead to false low or high patient results, risking erroneous diagnoses.
No specific incidents have been reported, but the potential for erroneous patient results poses serious risks to diagnosis.
Stop using the affected devices immediately. Follow the manufacturer's recall instructions. Contact Beckman Coulter, Inc. or your healthcare provider for further instructions.
For assistance, contact Beckman Coulter at the recall hotline or visit their website. Detailed recall instructions are available through their customer service.
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