FDA-Device2021-07-14Class II
Randox RX Imola Analyser with ISE, Catalog Numbers RX4900, RX4900R
Randox Laboratories Ltd.
Hazard
An issue was identified where the software froze during processing of commands, which resulted in no results displayed.
Sold states
US Nationwide Distribution and Puerto Rico.
Affected count
50 kits
Manufactured in
55 Diamond Road, Crumlin (North), Ireland
Products
Randox RX Imola Analyser with ISE, Catalog Numbers RX4900, RX4900R
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2013-2021Don't want to check this manually?
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