Beckman Coulter recalls North American iChemVELOCITY Urine Chemistry Analyzers with potential for incorrect settings causing false low results. Affected units include specific catalog numbers and configurations.
Beckman Coulter has determined that there is a potential for incorrect settings to be installed on North American iChemVELOCITY Urine Chemistry Analyzers. 1. The installation of International settings can result in the generation of erroneous, false low results for some of the analytes at some concentrations. 2. The installation of colors different from those stated in the Instructions for Use (Colorless, Straw, Yellow, Amber, Red, Blue) for output settings will result in incorrect reporting of colors. For example, if Green is the color choice for the output setting instead of Blue, Green will be reported.
Beckman Coulter is recalling certain North American iChemVELOCITY Urine Chemistry Analyzers because incorrect settings can produce false low results for some tests. This could lead to inaccurate urine test results, potentially affecting diagnosis of health conditions.
The system may install incorrect international settings, causing false low results for some analytes at certain concentrations. It can also misreport colors if different colors are selected than those specified in the instructions.
Healthcare professionals using the iChemVELOCITY Urine Chemistry System for clinical lab testing are most at risk. The recall affects specific catalog numbers sold in North America.
Check for catalog numbers: 800-3530, 800-7167, 800-7719, 800-7720, 800-7106, 800-3049, 800-3050, 800-3079, 800-3080, 800-7190, 800-7713, 800-7714, 800-7715, 700-7176-001, 700-7177-001. The product is used in clinical labs for urine chemistry analysis.
Identify your iChemVELOCITY Urine Chemistry Analyzer's catalog number to confirm if it's affected.
Incorrect settings may cause false low results for some tests and misreport colors, potentially leading to inaccurate urine test results.
No, but you should check your catalog number to see if it's affected. The recall does not require immediate discontinuation.
Check your catalog number against the list: 800-3530, 800-7167, 800-7719, 800-7720, 800-7106, 800-3049, 800-3050, 800-3079, 800-3080, 800-7190, 800-7713, 800-7714, 800-7715, 700-7176-001, 700-7177-001.
We’ve drafted a message you can send Beckman Coulter to request your refund or repair — edit it as you like.
Subject: Recall Z-1643-2018 — Beckman Coulter Beckman Coulter Hello, I own a Beckman Coulter that is covered by recall Z-1643-2018 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.
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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.
