Recall Z-0202-2024— Randox Laboratories Ltd.
Class II · Ongoing
Class II FDA medical device recall by Randox Laboratories Ltd., initiated 2023-09-06. FDA's recall record names no specific 510(k) clearance for this event. Product: RX Monaco-IVD Clinical Chemistry Analyser Catalog Number: RX5000. 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..
- Recalling firm
- Randox Laboratories Ltd.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2023-09-06
- Firm location
- Crumlin (North), N/A, Ireland
Product description
RX Monaco-IVD Clinical Chemistry Analyser Catalog Number: RX5000
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.