FDA recall Z-2013-2021

Product

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.

Distribution

US Nationwide Distribution and Puerto Rico.

Key facts

Status

Terminated

Initiation date

2021-04-28

Report date

2021-07-14

Termination date

2021-12-03

Voluntary/Mandated

Voluntary: Firm initiated

Location

Crumlin (North), Ireland

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2013-2021