Recall Z-1349-2020— Randox Laboratories, Limited
Class II · Terminated
Class II FDA medical device recall by Randox Laboratories, Limited, initiated 2019-12-19, terminated 2021-04-23. It names one FDA 510(k) clearance: K131554. 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: 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
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2019-12-19
- Terminated
- 2021-04-23
- Firm location
- Crumlin, N/A, United Kingdom
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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."
Data sourced from openFDA. This site is unofficial and independent of the FDA.