Randox recalls RX4900 clinical chemistry analyzers with potential for incorrect sample re-runs due to parameter settings. Affected units may report inaccurate results if samples are outside assay ranges.
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 RX4900 clinical chemistry analyzers and refurbished models (RX4900R) because improper sample re-run settings could cause inaccurate test results. This affects lab equipment used for medical testing, where incorrect results might lead to wrong diagnoses or treatments.
The analyzer's sample volume and dilution settings may not properly handle samples that fall outside the normal assay range. This can cause the re-run feature to malfunction, potentially leading to incorrect test results if samples are reprocessed.
Laboratories using Randox RX4900 analyzers for clinical testing are most at risk. The recall impacts medical facilities that rely on these devices for accurate diagnostic results.
Check for the RX4900 or RX4900R (refurbished) model with the catalog number. Affected units have specific lot/batch numbers listed in the recall notice.
Identify if your analyzer has the RX4900 or RX4900R model with the listed lot/batch numbers from the recall notice.
The recall is due to potential incorrect sample re-runs when samples are outside the normal assay range, which could lead to inaccurate test results.
Check if your analyzer has the specified lot/batch numbers. If it does, contact Randox for guidance on next steps.
The recall record does not mention any 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-0200-2024 — Randox Randox Hello, I own a Randox that is covered by recall Z-0200-2024 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.
