Randox recalls RX Daytona Plus analyzers with specific software versions due to sample display and color flagging issues in clinical labs. Affected models RX4040 and RX4041 require correction to prevent incorrect sample identification and IQC flagging.
Software version UI2550642107 for the RX Daytona + instrument released to correct the following issues: 1) The order of samples displayed is not sequential according to SID (sample identification number) when searching the run/results screen; 2) Incorrect color flagging of IQC as "out of range."
Randox is recalling specific models of their RX Daytona Plus clinical analyzers because software versions can display samples out of order and incorrectly flag quality control samples as out of range. This could lead to inaccurate test results if not corrected.
The software version UI2550642107 causes samples to not display in the correct order when searching results and incorrectly flags quality control samples as out of range. This could lead to inaccurate test results if not fixed.
Clinical laboratory users with RX Daytona Plus analyzers (models RX4040 and RX4041) are affected. Lab technicians and staff handling samples are most at risk of incorrect test results.
Check for RX Daytona Plus analyzers with model numbers RX4040 (with ISE) or RX4041 (without ISE). The affected software version is UI2550642107.
Verify the software version on your RX Daytona Plus analyzer; if it is UI2550642107, it is affected.
The software version UI2550642107 has issues with sample display order and incorrect color flagging of quality control samples as out of range.
The recall record does not specify a remedy for this software issue, so no action is required beyond checking the software version.
The recall indicates potential for inaccurate test results, but no serious injury risks are mentioned.
We’ve drafted a message you can send Randox to request your refund or repair — edit it as you like.
Subject: Recall Z-1349-2020 — Randox Randox Hello, I own a Randox that is covered by recall Z-1349-2020 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.
