Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1349-2020 — 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.

U.S. FDA — Device Enforcement · United Kingdom · 2019-12-19 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1349-2020
Date of alert: 2019-12-19
Country / jurisdiction: United Kingdom
Risk level: Class II
Risk type: recall
Brand: Randox Laboratories, Limited
Product category: device
Product type: Devices

Reported risk: 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."

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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Recall Z-1349-2020 — 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.

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