Z-0736-2018 Class I Terminated
Recall Details
- Product Type
- Devices
- Report Date
- March 7, 2018
- Initiation Date
- December 19, 2017
- Termination Date
- November 22, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 5040 units
Product Description
OptiView Amplification Kit, Ventana Part Number 760-099, Roche GMMI 06396518001 in vitro diagnostic
Reason for Recall
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.
Distribution Pattern
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,
Code Information
UDI 04015630983834, Lot Numbers: Y15435, Y19322, Y22447