Randox Laboratories Ltd. 55 Diamond Road Crumlin (North) Ireland RX Monaco-IVD Clinical Chemistry Analyser Catalog Number: RX5000 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
RX Monaco-IVD Clinical Chemistry Analyser Catalog Number: RX5000
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: 05055273207750 Lot/ Batch Number 230T240CS0126S 210T240CS0258S S180T240CS0486MA S180T240CS0487MA S180T240CS0483MA S180T240CS0218MA S170T240CS0665MA S160T240CS0111MA S160T240CS0110MA S150T240CS0005MA S140T240CS0185MA S140T240CS0017MA S140T240CS0015MA
Randox Laboratories Ltd. 55 Diamond Road Crumlin (North) Ireland is recalling RX Monaco-IVD Clinical Chemistry Analyser Catalog Number: RX5000 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