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Randox Laboratories, Limited recalls RX Daytona Plus (with ISE/without ISE); Models Nos. RX4040 (w/ISE) and RX4041 (without ISE) - Product Usage: A fully au
Recalled March 4, 2020 · FDA recall Z-1349-2020 · Randox Laboratories
Hazard
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." · FDA Class II
Units
U.S.: RX4040-2 units RX 4041-3 units
Sold at
US Nationwide distribution including state of PR.
Description
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."
Product
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.
Manufacturer(s)
Randox Laboratories, Limited
Made in
United Kingdom
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →