FDAFDA · Food and drugs·Recall number Z-1374-2022
Ventana HE 600 System, automated slide preparer, for use in laboratories.
Published July 20, 2022 · Recall initiated: June 1, 2022
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
There is a potential for fluid leak inside the Ventana HE 600 instrument which could result in electrical short and fire
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Ventana Medical Systems Inc
- Distributor
- 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
- Lot
- All Lots; UDI/DI: 04015630976010
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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