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Recall Observatory FDA recall evidence

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.

Z-1349-2020

December 19, 2019

Class II

Product summary

Firm
Randox Laboratories, Limited
Event
Event 84649
Status
Terminated
Classification
Class II
Quantity
U.S.: RX4040-2 units RX 4041-3 units
Official record key
device-enforcement:Z-1349-2020

Official wording

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."

Code information: Software version UI2550642107 for the RX Daytona Plus instrument.

Distribution pattern: US Nationwide distribution including state of PR.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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."