Beckman Coulter recalls 160 DxC 500i Clinical Analyzer Modules and the DxI 9000 Access Immunoassay Analyzer worldwide after a software anomaly could misapply manual dilution factors. The defect affects samples already in progress using the same Sample ID. Stop using the devices immediately and follow the recall instructions. Beckman Coulter will provide instructions via the recall process.
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
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DxC 500i modules and the DxI 9000 Access Immunoassay Analyzer are clinical laboratory instruments used for chemistry and immunoassay testing in healthcare settings.
A software anomaly can misapply manual dilution factors for tests ordered on samples in progress, risking inaccurate results and delayed reporting.
This recall is not described as part of a broader industry pattern.
The defect could lead to incorrect patient results and reporting delays, potentially impacting diagnosis and treatment.
Recall notice and enforcement page at the FDA link: https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-0215-2026
Resolution or remediation guidance will be provided by Beckman Coulter through the recall letter. Expect weeks to months depending on device and site.
Keep the recall notification, serial/model lists, and all correspondence with Beckman Coulter for future reference.
- Brand: Beckman Coulter - Product: DxC 500i Clinical Analyzer Modules; DxC 500 AU Module w/ISE; DxI 9000 Access Immunoassay Analyzer - Models/Part Numbers: C63522, C63521, C13252 - Serial Numbers: 750198, 750058, 750222, 750128, 750138, 750069, 750050, 750055, 750179, 750180, 750181, 750109, 750168, 750104, 750211, 750073, 750210, 750209, 750178, 750151, 750153, 750152, 750155, 750185, 750187, 750188, 750195, 750196, 750201, 750197, 750199, 750204, 750202, 750205, 750083, 750079, 750186, 750052, 750230, 750228, 750140, 750077, 750135, 750130, 750167, 750095, 750105, 750175, 750132, 750082, 0
No injuries or incidents have been reported.
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