# FDA recall Z-1349-2020

> **Randox Laboratories, Limited** · Class II · device recall initiated 2019-12-19.

## 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 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

US Nationwide distribution including state of PR.

## Key facts

- **Recall number:** Z-1349-2020
- **Recalling firm:** Randox Laboratories, Limited
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-12-19
- **Report date:** 2020-03-04
- **Termination date:** 2021-04-23

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Crumlin, N/A, United Kingdom

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1349-2020

## Citation

> AI Analytics. FDA recall Z-1349-2020. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-1349-2020. Source: US FDA. Licensed CC0.

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