Z-1349-2020 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- March 4, 2020
- Initiation Date
- December 19, 2019
- Termination Date
- April 23, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- U.S.: RX4040-2 units RX 4041-3 units
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."
Distribution Pattern
US Nationwide distribution including state of PR.
Code Information
Software version UI2550642107 for the RX Daytona Plus instrument.