Recall Z-0201-2024

Reason for recall

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.

FDA-determined cause: Under Investigation by firm

Action taken

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.