Beckman Coulter recalls UniCel DxI 600 and 800 Access Immunoassay Systems with specific software versions and serial numbers. When racks are front-loaded during sample processing, a software scheduling error can cause incorrect test results, typically showing falsely decreased results by up to 100%.
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 UniCel DxI 600 and 800 Access Immunoassay Systems that connect to automation lines. When racks are front-loaded while samples are being processed, a software error can cause test results to be incorrect—typically showing falsely decreased results by up to 100%. This could lead to inaccurate medical diagnoses.
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 aliquot creation. This leads to incorrect results, typically showing falsely decreased values by up to 100% (though falsely elevated results are also possible).
Laboratory users with the specific UniCel DxI 600 or 800 Access systems listed in the recall. Most at risk are those who regularly process samples with these systems and may not have noticed the error in results.
Check if your UniCel DxI 600 or 800 Access system has a catalog number from the list (A30260, A71460, A71461, A92060 for 600; 973100, A71456, etc. for 800) or a serial number from the provided list. Systems running software versions 5.2, 5.3.0, 5.3.1 are also affected.
Verify your UniCel DxI 600 or 800 Access system's catalog number or serial number against the lists provided in the recall.
If your system is affected, contact Beckman Coulter for instructions on how to address the issue.
UniCel DxI 600 with catalog numbers A30260, A71460, A71461, A92060 and UniCel DxI 800 with catalog numbers 973100, A71456, A71457, A84545, A25288, A25285.
Systems running software versions 5.2, 5.3.0, or 5.3.1 are affected.
When racks are front-loaded during sample processing, a software scheduling error can cause test results to be incorrect—typically showing falsely decreased results by up to 100% (though falsely elevated results are also possible).
We’ve drafted a message you can send Beckman Coulter to request your refund or repair — edit it as you like.
Subject: Recall Z-1077-2019 — Beckman Coulter Beckman Coulter Hello, I own a Beckman Coulter that is covered by recall Z-1077-2019 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.
