FDA Enforcement
Class I
Terminated
ultraView SISH DNP Detection Kit US, Ventana Part Number 760-098, Roche GMMI 05572037001 in vitro diagnostic
Recall: Z-0733-2018
·
Reported March 7, 2018
Enforcement
- Recall Number
- Z-0733-2018
- Event ID
- 78942
- Classification
- Class I
- Status
- Terminated
- Product Type
- Devices
- Firm
- Ventana Medical Systems Inc
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- March 7, 2018
- Initiation Date
- December 19, 2017
- Classification Date
- September 14, 2018
- Termination Date
- November 22, 2021
- Address
- 1910 E Innovation Park Dr, N/A, Oro Valley, AZ, 85755-1962, United States
Description
ultraView SISH DNP Detection Kit US, Ventana Part Number 760-098, Roche GMMI 05572037001 in vitro diagnostic
Reason
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.
Code Info
UDI 04015630970384, Lot Number: Y15146
Distribution
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,
Quantity
20 units