Beckman Coulter recalls iQ200 Series Urine Microscopy Analyzers with specific catalog numbers due to potential under-reporting of casts in urine tests. Affected units may require software reconfiguration to prevent inaccurate results.
Beckman Coulter has determined that there is a potential for under-reporting casts. This can occur if per high-power field (/HPF) units of measurement for casts are selected in the iQ200 software, but the abnormal threshold and/or grading format is set up based on reporting per low-power field (/LPF)* or *per microliter. This may occur during initial method validation or if settings are altered after the initial validation.
Beckman Coulter is recalling certain iQ200 Series Urine Microscopy Analyzers because they might under-report casts in urine tests. This could lead to inaccurate test results if the software settings are not correctly configured for high-power field measurements.
The device may under-report casts in urine tests if the software settings for high-power field units are selected but the grading format is based on low-power field or per microliter measurements. This error can happen during initial setup or if settings are changed after validation.
Healthcare providers and labs using the iQ200 Series Urine Microscopy Analyzers with the listed catalog numbers are most at risk. Patients using these analyzers for urine tests may receive inaccurate results if the device is misconfigured.
Check for catalog numbers: 700-3345, C10684, 700-3375, C10683, 700-3325, 700-3347, 700-3320, 700-3322, 700-3370. The device is part of the iQ200 Series Urine Microscopy Analyzer product line.
Verify that the device is configured for high-power field measurements and not using low-power field or per microliter settings.
Beckman Coulter has determined that the device may under-report casts in urine tests if the software settings are incorrectly configured for high-power field measurements but the grading format is based on low-power field or per microliter.
The affected catalog numbers are 700-3345, C10684, 700-3375, C10683, 700-3325, 700-3347, 700-3320, 700-3322, and 700-3370.
Ensure the device is set up correctly for high-power field measurements and not using low-power field or per microliter settings during initial validation or after any changes to the settings.
We’ve drafted a message you can send Beckman Coulter to request your refund or repair — edit it as you like.
Subject: Recall Z-1362-2018 — Beckman Coulter Beckman Coulter Hello, I own a Beckman Coulter that is covered by recall Z-1362-2018 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
