Randox recalls RX Daytona Plus analyzers (catalog RX4040) due to potential incorrect re-run settings causing inaccurate test results. Affected units have specific lot numbers.
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 (catalog number RX4040) because incorrect re-run settings may cause inaccurate test results. This could lead to incorrect medical diagnoses if the device is used improperly.
The device may report incorrect test results when samples are outside the normal assay range due to improper re-run settings. This could lead to inaccurate medical diagnoses if the analyzer is used without proper calibration.
Healthcare facilities using Randox RX Daytona Plus analyzers with catalog number RX4040 are most at risk. The recall affects specific lot numbers produced between 2022 and 2023.
Check for the catalog number RX4040 on the device. Affected units have specific lot numbers: 7241-0551, 7241-0545, 7241-0531, 7241-0317, or 7241-0219.
Look for the lot numbers 7241-0551, 7241-0545, 7241-0531, 7241-0317, or 7241-0219 on the device.
The recall is due to potential incorrect re-run settings that could cause inaccurate test results when samples are outside the normal assay range.
Check the lot number on your device. If it matches the listed numbers (7241-0551, 7241-0545, 7241-0531, 7241-0317, or 7241-0219), contact Randox for further instructions.
The device is safe to use if the lot number is not listed in the recall. If it is listed, contact Randox for guidance.
We’ve drafted a message you can send Randox to request your refund or repair — edit it as you like.
Subject: Recall Z-0198-2024 — Randox Randox Hello, I own a Randox that is covered by recall Z-0198-2024 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.
