Beckman Coulter recalls DxU 840m Iris Urine Microscopy Analyzers with Windows 10 and specific software versions due to a flag issue that may cause sample carryover events.
Beckman Coulter has become aware of an intermittent issue in which the optional flag "Previous Sample Had Sperm" was enabled but not displayed so that a carryover event could have been investigated.
Beckman Coulter is recalling certain DxU 840m Iris Urine Microscopy Analyzers that have a software issue where a specific flag might not display properly, potentially causing sample carryover. This could lead to inaccurate urine test results if the device is used without proper cleaning between samples.
The device has a software issue where the 'Previous Sample Had Sperm' flag is enabled but not displayed. This could cause the analyzer to investigate a carryover event between samples, potentially leading to inaccurate test results if the device is not properly cleaned between uses.
Users of the DxU 840m Iris Urine Microscopy Analyzer with Windows 10 and software versions 8.5, 8.5.1, or 8.6 are affected. Laboratory technicians and healthcare providers who perform urine tests with these devices are most at risk.
Check for the DxU 840m Iris Urine Microscopy Analyzer with Catalog Number C76947. The device must have Windows 10 and software versions 8.5, 8.5.1, or 8.6 to be affected.
Verify the software version on your device to see if it is 8.5, 8.5.1, or 8.6.
The device has a software issue where the 'Previous Sample Had Sperm' flag is enabled but not displayed, which could cause a carryover event between samples.
No, the recall does not require immediate discontinuation. Users should check the software version and follow the provided steps.
Your device is affected if it has Windows 10 and software versions 8.5, 8.5.1, or 8.6, as indicated by the Catalog Number C76947.
We’ve drafted a message you can send Beckman Coulter to request your refund or repair — edit it as you like.
Subject: Recall Z-1598-2023 — Beckman Coulter Beckman Coulter Hello, I own a Beckman Coulter that is covered by recall Z-1598-2023 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.
