FDA recall Z-1374-2022

Product

Ventana HE 600 System, automated slide preparer, for use in laboratories.

Reason for recall

There is a potential for fluid leak inside the Ventana HE 600 instrument which could result in electrical short and fire

Distribution

US: AL AR AZ CA CO CT DC FL GA HI IA IL IN KS KY MA MD MI MN MO MS MT NC NE NJ NY OH OK OR PA PR SC SD TN TX UT VA WA WI WV OUS: Canada, Austria, Belgium, Croatia, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Luxembourg, Netherlands, Norway, Poland, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey, UK, Argentina, Australia, Brazil, Chile, China, Colombia, Costa Rica, Ecuador, Egypt, El Salvador, Guatemala, Hong Kong, Israel, Japan, Kuwait, Lebanon, Malaysia, Saudi Arabia, Singapore, South Korea, Taiwan, Thailand, United Arab Emirates (UAE), Vietnam

Key facts

Status

Ongoing

Initiation date

2022-06-01

Report date

2022-07-20

Voluntary/Mandated

Voluntary: Firm initiated

Location

Oro Valley, AZ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1374-2022