Beckman Coulter recalls iQ200 Series Urine Microscopy Analyzers with specific part numbers due to potential rust in the cannula causing inaccurate test results. Affected units may need replacement.
Beckman Coulter has become aware that the cannula, which is found in the Flowcell and the iQClear Rinse Waste Well Assembly, may rust. Rust from the cannula has the potential to generate erroneous results.
Beckman Coulter is recalling iQ200 Series Urine Microscopy Analyzers with certain part numbers because rust in the cannula could lead to inaccurate test results. This affects laboratory users who rely on these analyzers for urine tests.
The cannula in the Flowcell and iQClear Rinse Waste Well Assembly may rust, which can cause the analyzers to produce incorrect test results. This means urine test results might be inaccurate due to the rusted component.
Laboratory users who own or use the iQ200 Series Urine Microscopy Analyzers with the listed part numbers are most at risk. The hazard is specific to the cannula component and does not pose an immediate safety threat.
Check the product for part numbers: 700-3320, 700-3370, 700-3345, 700-3347, C10683, or other listed part numbers. The units also have unique identifiers (UDI/DI) as listed in the recall notice.
Identify if your analyzer has part numbers 700-3320, 700-3370, 700-3345, 700-3347, or C10683.
The recall is due to potential rust in the cannula that could cause inaccurate test results.
Check the part numbers listed: 700-3320, 700-3370, 700-3345, 700-3347, C10683, or other specific part numbers provided in the recall notice.
No action is required if your analyzer does not have the listed part numbers.
We’ve drafted a message you can send Beckman Coulter to request your refund or repair — edit it as you like.
Subject: Recall Z-0785-2024 — Beckman Coulter Beckman Coulter Hello, I own a Beckman Coulter that is covered by recall Z-0785-2024 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.
