RX Daytona Plus (with ISE/without ISE); Models Nos. RX4040 (w/ISE) and RX4041 (without ISE) - Pro...
FDA Recall #Z-1349-2020 — Class II — December 19, 2019
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.
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."
Recalling Firm
Randox Laboratories, Limited — Crumlin, N/A
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
U.S.: RX4040-2 units RX 4041-3 units
Distribution
US Nationwide distribution including state of PR.
Code Information
Software version UI2550642107 for the RX Daytona Plus instrument.
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated