Beckman Coulter recalls DxA 5000 lab equipment due to software defect that may cause tests on incompatible patient samples, leading to erroneous results. Affected units include those with specific serial numbers and model.
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 5000 lab equipment because a software issue might cause tests to run on patient samples that aren't compatible with the requested test, resulting in incorrect results. This could affect lab accuracy and patient care.
The software defect may cause the system to run tests on patient samples in tube types that aren't compatible with the test being performed. This can lead to incorrect patient results, potentially affecting diagnosis and treatment decisions.
Lab technicians and healthcare facilities using the DxA 5000 system are most at risk. The recall affects specific units with the described serial numbers and model.
Check for the DxA 5000 system with the specific serial numbers listed in the recall notice. The product includes the model and voltage specifications mentioned in the recall.
Identify the system's serial number to confirm if it is affected by this recall.
The DxA 5000 system with the specific serial numbers listed in the recall notice.
The defect may cause tests to run on patient samples in tube types not compatible with the requested test, leading to incorrect results.
The recall notice does not specify a remedy, so users should check the serial number and contact Beckman Coulter for further guidance.
We’ve drafted a message you can send Beckman Coulter to request your refund or repair — edit it as you like.
Subject: Recall Z-2144-2023 — Beckman Coulter Beckman Coulter Hello, I own a Beckman Coulter that is covered by recall Z-2144-2023 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.