FDA-Device2023-11-08Class II
RX Daytona Plus (without ISE)- IVD Clinical Chemistry Analyser (1) RX4041, (2) RX4041R (refurbished)
Randox Laboratories Ltd.
Hazard
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.
Sold states
US Nationwide distribution including Puerto Rico
Affected count
6 units
Manufactured in
55 Diamond Road, N/A, Crumlin (North), N/A, Ireland
Products
RX Daytona Plus (without ISE)- IVD Clinical Chemistry Analyser (1) RX4041, (2) RX4041R (refurbished)
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0199-2024Don't want to check this manually?
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