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

Recall date

May 4, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2059-2018

FDA classification

Class II

Brand / firm

Randox Laboratories

Sold / distributed

US Distribution including Puerto Rico and the state of : West Virginia.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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