Beckman Coulter recalls UniCel DxC 660i, 680i, 860i, and 880i systems with software reconfiguration that may cause incorrect lab results due to sample mishandling during aliquot creation.
When racks are front-loaded onto the sample presentation unit while samples from the automation line are being processed, a scheduling error within the software can cause mishandling of samples during the creation of an aliquot and lead to incorrect results being generated. Affected samples typically yield non-reproducible falsely decreased results by up to 100%, however the potential for falsely elevated results cannot be ruled out.
Beckman Coulter is recalling specific clinical lab systems that were reconfigured to separate the DxI system from the DxC system. This reconfiguration can cause samples to be mishandled during aliquot creation, potentially generating incorrect lab results with up to 100% falsely decreased values.
When racks are front-loaded onto the sample presentation unit while samples are being processed, a software scheduling error can cause samples to be mishandled during aliquot creation. This may lead to incorrect lab results, with affected samples typically showing non-reproducible falsely decreased results by up to 100%.
Lab users with the UniCel DxC 660i, 680i, 860i, or 880i systems that were reconfigured to separate the DxI system from the DxC system. Clinical lab technicians and healthcare providers using these systems are most at risk.
Check for UniCel DxC 660i (A64871), 680i (A64903), 860i (A64935), or 880i (A59102) systems running software versions 5.2, 5.3.0, or 5.3.1 that were reconfigured to separate the DxI system from the DxC system.
Verify if your system was reconfigured to separate the DxI system from the DxC system by checking the software version and catalog number.
UniCel DxC 660i (A64871), 680i (A64903), 860i (A64935), and 880i (A59102) systems running software versions 5.2, 5.3.0, or 5.3.1.
The reconfiguration can cause samples to be mishandled during aliquot creation, potentially generating incorrect lab results with up to 100% falsely decreased values.
Yes, check if your system was reconfigured to separate the DxI system from the DxC system. If so, contact Beckman Coulter for 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-1078-2019 — Beckman Coulter Beckman Coulter Hello, I own a Beckman Coulter that is covered by recall Z-1078-2019 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.
