Randox Laboratories Ltd. 55 Diamond Road Crumlin (North) Ireland RX Daytona Plus (with ISE)-IVD Clinical Chemistry Analyser Catalog Number: RX4040 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
RX Daytona Plus (with ISE)-IVD Clinical Chemistry Analyser Catalog Number: RX4040
Brand
Randox Laboratories Ltd. 55 Diamond Road Crumlin (North) Ireland
Lot Codes / Batch Numbers
Not specified in FDA notice. Check official source for details.
Products Sold
GTIN: 05055273207774 Lot/ Batch Number (1) Lot/ Batch Number 7241-0551 7241-0545 7241-0531 7241-0317 7241-0219
Randox Laboratories Ltd. 55 Diamond Road Crumlin (North) Ireland is recalling RX Daytona Plus (with ISE)-IVD Clinical Chemistry Analyser Catalog Number: RX4040 due to RX Parameter rerun settings (Sample Volume Low/High), and Dilutions used for Auto reruns, not meeting sample re-run conditions when samples are above. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
RX Parameter rerun settings (Sample Volume Low/High), and Dilutions used for Auto reruns, not meeting sample re-run conditions when samples are above or below assay range and may result i issues with the re-run feature conditions when incorrectly. Potential to report incorrectly.
Recommended Action
Per FDA guidance
Randox issued Medical Device Correction letter (REC687) on 9/13/23 to to US and PR customers on 9/12/23. Letter states reason for recall, health risk and action to take: Randox recommendations: " Auto rerun settings are disabled, see Appendix A for guidance for each Rx instrument. " Results with flag(<) reported as the bottom of the technical range. Sample Volume settings Low should not be applied. " Results with flag (>) reported as the top of the technical range. Sample Volume settings high and dilutions should not be applied. A manual dilution should be performed, and results multiplied by the dilution factor. The RX Parameter rerun settings will be updated with a parameter release in due course, the Instructions For Use will also be updated at this time. Action to be taken: " Discuss the contents of this notice with your Medical Director. " Complete and return the response form 12187-QA to technical.services@randox.com within five working days. Transmission of Field Safety Notice: Send a copy of the FSN to all affected customers and to those who need to be aware within your organisation.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026