Randox recalls RX Monaco-IVD Clinical Chemistry Analyser (RX5000) due to potential incorrect sample rerun settings causing inaccurate test results. Affected units may need recalibration or software updates.
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 RX Monaco-IVD Clinical Chemistry Analyser (RX5000) because improper sample rerun settings could lead to inaccurate test results. This affects laboratory equipment that processes medical samples.
The analyser may report incorrect results when samples are outside the normal test range due to improper rerun settings. This happens when the sample volume or dilution settings are not correctly adjusted for re-running tests.
Laboratories using the RX Monaco-IVD Clinical Chemistry Analyser (RX5000) with specific lot numbers are affected. Medical professionals and lab staff handling samples are most at risk of inaccurate test results.
Check for the RX Monaco-IVD Clinical Chemistry Analyser with catalog number RX5000 and specific lot numbers listed in the recall notice: 230T240CS0126S, 210T240CS0258S, S180T240CS0486MA, S180T240CS0487MA, S180T240CS0483MA, S180T240CS0218MA, S170T240CS0665MA, S160T240CS0111MA, S160T240CS0110MA, S150T240CS0005MA, S140T240CS0185MA, S140T240CS0017MA, S140T240CS0015MA.
Identify the lot number on your RX Monaco-IVD Clinical Chemistry Analyser (RX5000) to see if it matches the listed numbers in the recall.
The recall is due to potential incorrect sample rerun settings that could cause inaccurate test results when samples are outside the normal test range.
Check the lot number on your device against the list provided in the recall notice to determine if it is affected.
The recall record does not specify a remedy or fix for this issue.
We’ve drafted a message you can send Randox to request your refund or repair — edit it as you like.
Subject: Recall Z-0202-2024 — Randox Randox Hello, I own a Randox that is covered by recall Z-0202-2024 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.
