Mar

2020

Recall – Chemistry analyzer software version released to correct display errors

Company: Randox Laboratories, Limited
Date of Enforcement Report: 3/11/2020
Class II

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.

Recall Number: Z-1349-2020

REASON

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.”

RECALLING FIRM/MANUFACTURER

Randox Laboratories, Limited on 12/19/2019. Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE

U.S.: RX4040-2 units RX 4041-3 units

DISTRIBUTION

US Nationwide

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