FDA-Device2020-03-04Class II
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.
Randox Laboratories, Limited
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."
Sold states
US Nationwide distribution including state of PR.
Affected count
U.S.: RX4040-2 units RX 4041-3 units
Manufactured in
Ardmore; 55 The Diamond Road, N/A, Crumlin, N/A, United Kingdom
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1349-2020Don't want to check this manually?
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