FDA-Device2023-11-08Class II
RX Imola-IVD Clinical Chemistry Analyzer Catalog Number: RX4900. RX4900R (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
35 units
Manufactured in
55 Diamond Road, N/A, Crumlin (North), N/A, Ireland
Products
RX Imola-IVD Clinical Chemistry Analyzer Catalog Number: RX4900. RX4900R (refurbished)
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0200-2024Don't want to check this manually?
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