Beckman Coulter recalls iQ200 Series Urine Microscopy Analyzers with specific catalog numbers due to reported duplicate specimen identifiers causing inconsistent results. Affected users should check their device model and contact the company for details.
Customers have reported incidents where two sets of results report the same Specimen Identifier (Specimen ID) with different results, different Medical Record Number (MRN) and different patient identification (demographics).
Beckman Coulter is recalling certain iQ200 Series Urine Microscopy Analyzers because they may report the same specimen identifier with different results, medical record numbers, and patient details. This could lead to incorrect medical diagnoses if the device is used in healthcare settings.
The device may report the same specimen identifier with different results, medical record numbers, and patient details. This inconsistency could lead to incorrect medical diagnoses if the device is used in healthcare settings.
Healthcare professionals using the iQ200 Series Urine Microscopy Analyzers for urine testing are most at risk. Patients receiving results from these devices may also be affected if the device is used in clinical settings.
Check for catalog numbers: 700-3345, 700-3375, 700-3325, 700-3347, 700-3300RFB, 700-3320, 700-3320RFB, 700-3322, 700-3322RFB, 700-3326, 700-3340, 700-3370, B48999, C10683, C10684. The device is used for urine testing in clinical settings.
Verify your iQ200 Series Urine Microscopy Analyzer's catalog number to see if it is listed in the recall.
Beckman Coulter has reported incidents where two sets of results report the same specimen identifier with different results, medical record numbers, and patient details.
Check your device's catalog number to see if it is affected. If it is, contact Beckman Coulter for further instructions.
The recall record does not mention a specific remedy or fix for this issue.
We’ve drafted a message you can send Beckman Coulter to request your refund or repair — edit it as you like.
Subject: Recall Z-0914-2020 — Beckman Coulter Beckman Coulter Hello, I own a Beckman Coulter that is covered by recall Z-0914-2020 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.
