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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