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Randox Laboratories recalls RX Imola (RX4900) For Professional Use for the quantitative in vitro determination of various clinical chemistry test
Recalled June 13, 2018 · FDA recall Z-2059-2018 · 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. · FDA Class II
Units
41 analyzers
Sold at
US Distribution including Puerto Rico and the state of : West Virginia.
Description
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.
Product
RX Imola (RX4900) For Professional Use for the quantitative in vitro determination of various clinical chemistry tests.
Manufacturer(s)
Randox Laboratories
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →