Recall Z-0200-2024 ยท CEM Electrode, Ion Specific, Potassium
Randox Laboratories Ltd.
RX Imola-IVD Clinical Chemistry Analyzer Catalog Number: RX4900. RX4900R (refurbished)
| Date | Oct 31, 2023 (initiated Sep 6, 2023) |
| Status | Open, Classified |
| Reason | 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. |
| Root cause | Under Investigation by firm |
| Action | 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 |
| Quantity | 35 units |
| Distribution | US Nationwide distribution including Puerto Rico |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K052914 | RX IMOLA Randox Laboratories, Ltd., Mar 31, 2006 |