Beckman Coulter recalled 571 DxI 9000 Access Immunoassay Analyzers and DxC 500i Clinical Analyzers distributed worldwide. A software anomaly may prevent correct application of manual dilution factors for tests already in progress on the same Sample ID. Labs should stop using the devices 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
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DxI 9000 and DxC 500i are clinical chemistry instruments used in hospital and reference labs to perform immunoassays and deliver patient results.
A software anomaly can misapply manual dilution factors for tests ordered on in-progress samples using the same Sample ID, risking inaccurate results and delayed reporting.
This recall is not described as part of a broader industry pattern.
Laboratories may face result inaccuracies and reporting delays that could affect patient care and clinical decision making.
FDA recall page for Z-0216-2026 and Beckman Coulter recall notice
Remediation timelines are coordinated by the manufacturer; typically weeks for replacement or service arrangements.
Keep copies of the recall notice, serial number lists, and all communications with the manufacturer and regulatory bodies.
DxI 9000 Access Immunoassay Analyzer, Part Number C11137. DxC 500i Clinical Analyzer. UDI-DI: 15099590732103. Serial numbers: extensive list provided by recall. Quantity: 571 units. Distribution: Worldwide with US nationwide distribution. Sold worldwide; no retailer-specific listing available. Price: Not disclosed.
No injuries or incidents have been reported.
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