Beckman Coulter recalls DxA Automation System models due to software defect that may cause incorrect patient test results. Affected units include DxA 5000 Fit with specific serial numbers. Contact for remedy details.
A software defect in the DxA Automation System may cause tests to be run on patient samples in tube types not compatible with the requested test, leading to erroneous patient results
Beckman Coulter is recalling its DxA Automation System models because a software defect could cause tests to be run on incompatible patient samples, leading to incorrect results. This affects laboratory equipment used for medical testing.
The software defect may cause the system to run tests on patient samples in tube types that are not compatible with the requested test. This can lead to incorrect patient results, which might affect medical decisions.
Laboratories using Beckman Coulter DxA Automation System models are affected. Medical professionals and lab technicians who handle patient samples with these devices are most at risk.
Check for the DxA Automation System model with serial numbers starting with 'All DxA serial numbers' as listed in the recall notice. The product includes specific electrical specifications like 200240V, 16A, 50/60HZ.
Look for the serial number on the device or in the product documentation to confirm if it is affected.
The DxA 5000 Fit model with serial numbers starting with 'All DxA serial numbers' as listed in the recall notice.
A software defect may cause tests to be run on patient samples in tube types not compatible with the requested test, leading to incorrect patient results.
The recall notice does not specify a remedy, so contact Beckman Coulter directly for further instructions.
We’ve drafted a message you can send Beckman Coulter to request your refund or repair — edit it as you like.
Subject: Recall Z-2145-2023 — Beckman Coulter Beckman Coulter Hello, I own a Beckman Coulter that is covered by recall Z-2145-2023 from Beckman Coulter. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
