FDA-Device2018-06-13Class II
RX Imola (RX4900) For Professional Use for the quantitative in vitro determination of various clinical chemistry tests.
Randox Laboratories
Hazard
Abnormal premature termination of the software could affect the use of the analyser when running patient samples. The impact being a delay in reporting test results.
Sold states
US Distribution including Puerto Rico and the state of : West Virginia.
Affected count
41 analyzers
Manufactured in
515 Industrial Blvd, N/A, Kearneysville, WV, United States
Products
RX Imola (RX4900) For Professional Use for the quantitative in vitro determination of various clinical chemistry tests.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2059-2018Don't want to check this manually?
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