Beckman Coulter recalls UA WIN 10 Kit (C52900) with Windows 10 software versions 8.5-8.6 due to potential carryover events from previous samples.
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 their UA WIN 10 urine analysis kit because a specific flag setting might cause incorrect results from previous samples. This could lead to misdiagnosis if the system doesn't properly clear between tests.
The optional flag 'Previous Sample Had Sperm' is enabled but not displayed in the software. This could cause the system to investigate a carryover event from a previous sample, potentially leading to incorrect test results.
Users of Beckman Coulter UA WIN 10 urine analysis kits with Windows 10 software versions 8.5, 8.5.1, or 8.6 are affected. Lab technicians and healthcare providers using these kits for urine testing are most at risk.
Check for the UA WIN 10 Kit with catalog number C52900. The kit is sold with Windows 10 analyzers and software versions 8.5, 8.5.1, or 8.6.
Verify your software version by checking the analyzer's menu settings.
No, the recall is for a potential issue with a specific flag setting that could cause incorrect results, not a safety hazard.
Your kit is affected if it has catalog number C52900 and is used with Windows 10 analyzers running software versions 8.5, 8.5.1, or 8.6.
The recall does not require immediate action; check your software version and monitor for potential issues.
We’ve drafted a message you can send Beckman Coul: Inc. to request your refund or repair — edit it as you like.
Subject: Recall Z-1599-2023 — Beckman Coul: Inc. Beckman Coul: Inc. Hello, I own a Beckman Coul: Inc. that is covered by recall Z-1599-2023 from Beckman Coul: Inc.. 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.
