Randox Laboratories, Limited: Medical Device Recall in 2020 - (Recall #: Z-1349-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: December 19, 2019

Date Posted: March 4, 2020

Recall Number: Z-1349-2020

Event ID: 84649

Reason for Recall:

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."

Status: Terminated

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

Code Information:

Software version UI2550642107 for the RX Daytona Plus instrument.

Distribution Pattern:

US Nationwide distribution including state of PR.

Voluntary or Mandated:

Voluntary: Firm initiated