PlainRecalls
FDA Devices Moderate Class II Terminated

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

Reported: July 14, 2021 Initiated: April 28, 2021 #Z-2013-2021

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.

Details

Recalling Firm
Randox Laboratories Ltd.
Units Affected
50 kits
Distribution
US Nationwide Distribution and Puerto Rico.
Location
Crumlin (North)

Frequently Asked Questions

What product was recalled?
Randox RX Imola Analyser with ISE, Catalog Numbers RX4900, RX4900R. Recalled by Randox Laboratories Ltd.. Units affected: 50 kits.
Why was this product recalled?
An issue was identified where the software froze during processing of commands, which resulted in no results displayed.
Which agency issued this recall?
This recall was issued by the FDA Devices on July 14, 2021. Severity: Moderate. Recall number: Z-2013-2021.