Randox Laboratories, Limited recalls RX Imola, Model Nos. RX4900

Recall date

June 24, 2019

Source

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

Recall number

Z-2084-2019

FDA classification

Class II

Brand / firm

Randox Laboratories, Limited

Sold / distributed

Domestic distribution to CA CT MA MD MO NC NJ NY OH PA UT WV and PR. Worldwide foreign distribution.

Why it was recalled

There was a report of a malfunction with the sensor which resulted in an increase of temperature leading to melting of internal wires and scorch damage to the internal structure of the instrument.

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, Model Nos. RX4900