Beckman Coulter recalls DxU 850m Iris Urine Microscopy Analyzers with Windows 10 and specific software versions due to a flag display issue that could lead to incorrect sample analysis.
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 850m Iris Urine Microscopy Analyzers because a specific software flag might not display properly, potentially causing incorrect results. This issue does not pose a physical safety risk but could affect test accuracy.
The optional flag 'Previous Sample Had Sperm' may be enabled but not displayed in the software. This could lead to incorrect analysis of urine samples, potentially causing misdiagnosis if sperm is present in the sample.
Users of the DxU 850m Iris Urine Microscopy Analyzer with Windows 10 and software versions 8.5, 8.5.1, or 8.6 are affected. Laboratory staff and healthcare providers who use this device for urine analysis are most at risk of inaccurate results.
Check for the DxU 850m Iris Urine Microscopy Analyzer with Catalog Number C49513. 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.
Reach out to Beckman Coulter for guidance on whether your device needs correction or update.
No, this recall does not pose a physical safety risk but could lead to inaccurate urine test results.
Software versions 8.5, 8.5.1, and 8.6 with Windows 10.
Check the software version on your DxU 850m Iris Urine Microscopy Analyzer; affected devices have Windows 10 and specific software versions.
We’ve drafted a message you can send Beckman Coulter to request your refund or repair — edit it as you like.
Subject: Recall Z-1597-2023 — Beckman Coulter Beckman Coulter Hello, I own a Beckman Coulter that is covered by recall Z-1597-2023 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.
