FDAFDA · Food and drugs·Recall number Z-0731-2018
iView DAB IHC Detection Kit, Ventana part Number 760-091, Roche GMMI 05266157001 in vitro diagnostic
Published March 7, 2018 · Recall initiated: December 19, 2017
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Increased reports of leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers (part of the iView, ultraView and OptiView detection kits, as well as CINtec PLUS Cytology Kit) and with Hematoxylin II.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Ventana Medical Systems Inc
- Distributor
- Worldwide distribution, including US nationwide, Argentina, Australia, Hong Kong, Indonesia, Philippines, Brazil, Chile, Thailand, Korea, Malaysia, New Zealand, Ecuador, Mexico, Pakistan, Vietnam, Germany, Japan, India, Colombia, Singapore, Uruguay, Peru, Canada, Taiwan, China,
- Lot
- UDI 04015630971749, Lot Numbers: Y11834, Y24245
- Risk classification
- Class I
- Area (FDA)
- device
- Country
- United States
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