Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
RX Daytona Plus (with ISE/without ISE) Recalled by Randox Laboratories, Limited Due to Software version UI2550642107 for the RX Daytona +...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Randox Laboratories, Limited directly.
Affected Products
RX Daytona Plus (with ISE/without ISE); Models Nos. RX4040 (w/ISE) and RX4041 (without ISE) - Product Usage: A fully automated, random access, clinical chemistry analyzer complete with dedicated analyzer software. For use in clinical laboratories.
Quantity: U.S.: RX4040-2 units RX 4041-3 units
Why Was This Recalled?
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."
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Randox Laboratories, Limited
Randox Laboratories, Limited has 13 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report