Beckman Coulter recalls iQ200 Series Urine Microscopy Analyzers with a flag display issue that may cause sample carryover errors. Affected models include iQ 200 Select and Elite with specific part numbers and Windows 10 software versions.
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 iQ200 Series Urine Microscopy Analyzers due to a potential issue where a specific flag (indicating previous sample had sperm) may not display properly. This could lead to incorrect analysis results if samples are carried over without proper cleaning.
The device may enable a flag indicating 'Previous Sample Had Sperm' but fail to display it, potentially causing sample carryover events. This could lead to inaccurate urine analysis results if the device is not properly cleaned between samples.
Users of Beckman Coulter iQ200 Series Urine Microscopy Analyzers with specific part numbers and Windows 10 software version 8.1 are affected. Laboratory technicians and healthcare providers using these devices are most at risk.
Check for part numbers C10683, C10684, 700-3325, 700-3345, 700-3347, or 700-3375 on the device. Also, ensure the device runs Windows 10 with Software Version 8.1.
Verify the software version is Windows 10 with Software Version 8.1 to confirm if the device is affected.
Beckman Coulter has identified an intermittent issue where the 'Previous Sample Had Sperm' flag may be enabled but not displayed, potentially causing sample carryover events.
iQ 200 Select (Part Numbers C10684 and 700-3345), iQ 200 Elite (Part Numbers C10683 and 700-3375), iQ200 Select 1500 (Part Number 700-3347), and iQ200 Sprint (Part Number 700-3325).
Check if your device runs Windows 10 with Software Version 8.1. If affected, contact Beckman Coulter for further instructions.
We’ve drafted a message you can send Beckman Coulter to request your refund or repair — edit it as you like.
Subject: Recall Z-1596-2023 — Beckman Coulter Beckman Coulter Hello, I own a Beckman Coulter that is covered by recall Z-1596-2023 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.
