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…

Recall date

December 19, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1349-2020

FDA classification

Class II

Brand / firm

Randox Laboratories, Limited

Sold / distributed

US Nationwide distribution including state of PR.

Why it was 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."

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.