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FDAMay 4, 2018device

RX Imola (RX4900) For Professional Use for the quantitative in vitro determination of various clinical chemistry tests.

Official recall recorded by the U.S. Food & Drug Administration.

The 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.

What to do

FDA enforcement status: Terminated

Brands named

randox laboratoriesrandox

UPCs

05055273206104

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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