FDA recall Z-1349-2020

Randox Laboratories, Limited · Class II · device

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.

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."

Distribution

US Nationwide distribution including state of PR.

Key facts

Status
Terminated
Initiation date
2019-12-19
Report date
2020-03-04
Termination date
2021-04-23
Voluntary/Mandated
Voluntary: Firm initiated
Location
Crumlin, N/A, United Kingdom

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1349-2020