Recall Z-2013-2021— Randox Laboratories Ltd.
Class II · Terminated
Class II FDA medical device recall by Randox Laboratories Ltd., initiated 2021-04-28, terminated 2021-12-03. FDA's recall record names no specific 510(k) clearance for this event. Product: Randox RX Imola Analyser with ISE, Catalog Numbers RX4900, RX4900R. Reason: An issue was identified where the software froze during processing of commands, which resulted in no results displayed..
- Recalling firm
- Randox Laboratories Ltd.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2021-04-28
- Terminated
- 2021-12-03
- Firm location
- Crumlin (North), Ireland
Product description
Randox RX Imola Analyser with ISE, Catalog Numbers RX4900, RX4900R
Reason for recall
An issue was identified where the software froze during processing of commands, which resulted in no results displayed.
Data sourced from openFDA. This site is unofficial and independent of the FDA.