Recall Z-0198-2024— Randox Laboratories Ltd.
Class II · Ongoing
Class II FDA medical device recall by Randox Laboratories Ltd., initiated 2023-09-06. It names one FDA 510(k) clearance: K024014. Product: RX Daytona Plus (with ISE)-IVD Clinical Chemistry Analyser Catalog Number: RX4040. 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
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
RX Daytona Plus (with ISE)-IVD Clinical Chemistry Analyser Catalog Number: RX4040
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.