Randox recalls RX9000 clinical chemistry analyser due to potential incorrect re-run settings causing inaccurate test results. Affected units may need correction to prevent errors in lab testing.
RX Parameter rerun settings (Sample Volume Low/High), and Dilutions used for Auto reruns, not meeting sample re-run conditions when samples are above or below assay range and may result i issues with the re-run feature conditions when incorrectly. Potential to report incorrectly.
Randox is recalling its RX9000 clinical chemistry analyser because incorrect re-run settings might cause inaccurate test results. This could lead to wrong lab reports if the device is used without proper adjustments.
The device may report incorrect results when samples are outside the normal test range due to improper re-run settings. This happens when the system doesn't follow correct procedures for re-running samples that are too high or too low.
Laboratories using Randox RX9000 analyser units are affected. Lab technicians and clinical staff who handle these devices are most at risk of inaccurate test results.
Check for the RX9000 model with catalog number RX9000. The recall covers units sold with GTIN: 05055273214963. Lot/batch numbers are not specified in the recall notice.
Verify that re-run settings for sample volume and dilutions are correctly configured to avoid inaccurate test results.
The recall addresses potential inaccurate test results, not immediate safety risks. The hazard level is low risk.
Check for the RX9000 model with catalog number RX9000. The recall covers units sold with GTIN: 05055273214963.
Ensure re-run settings are correctly configured to prevent inaccurate test results. No immediate action is required beyond checking settings.
We’ve drafted a message you can send Randox to request your refund or repair — edit it as you like.
Subject: Recall Z-0201-2024 — Randox Randox Hello, I own a Randox that is covered by recall Z-0201-2024 from Randox. 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.
