Randox recalls RX Daytona Plus analyzers (RX4041 and RX4041R) due to potential incorrect re-run settings causing sample errors. Affected units have specific lot numbers. Contact Randox for details.
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 Daytona Plus clinical chemistry analyzers (RX4041 and RX4041R) because incorrect re-run settings might cause inaccurate test results. This could lead to incorrect reports if samples are outside the normal test range.
The analyzers may not properly handle samples that are too high or too low for the test range, leading to incorrect re-run settings. This could cause inaccurate test results if samples fall outside the normal assay range.
Healthcare facilities using Randox RX Daytona Plus analyzers with specific lot numbers are affected. Laboratory staff and patients using these devices for clinical testing are at risk of incorrect results.
Check for the model RX4041 or RX4041R (refurbished) with lot numbers listed: 7241-0616, 7241-0582, 7241-0441, 7241-0425, 7241-0384 for RX4041, and 7241-0149 for RX4041R.
Identify your RX Daytona Plus model (RX4041 or RX4041R) and check if it matches the listed lot numbers.
The analyzers may have incorrect re-run settings for samples outside the normal test range, potentially causing inaccurate test results.
Check if your RX Daytona Plus model (RX4041 or RX4041R) has a lot number from the list: 7241-0616, 7241-0582, 7241-0441, 7241-0425, 7241-0384 for RX4041, or 7241-0149 for RX4041R.
The recall record does not specify a remedy, so contact Randox directly for further instructions.
We’ve drafted a message you can send Randox to request your refund or repair — edit it as you like.
Subject: Recall Z-0199-2024 — Randox Randox Hello, I own a Randox that is covered by recall Z-0199-2024 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.
