Medical device recalls Moderate risk

Randox Laboratories Ltd. recalls Randox RX Imola Analyser with ISE, Catalog Numbers RX4900, RX4900R

Recall date
April 28, 2021
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-2013-2021
FDA classification
Class II
Brand / firm
Randox Laboratories Ltd.
Sold / distributed
US Nationwide Distribution and Puerto Rico.

Why it was recalled

An issue was identified where the software froze during processing of commands, which resulted in no results displayed.

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

What was recalled

Randox RX Imola Analyser with ISE, Catalog Numbers RX4900, RX4900R

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