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