Z-0734-2018 Class I Terminated
FDA device recall Z-0734-2018 was initiated by Ventana Medical Systems Inc on December 19, 2017 and is designated Class I. 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)… The recall status is terminated (terminated November 22, 2021). Affected quantity: 748 units.
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
- 748 units
Product Description
CINtec PLUS Cytology Kit (CE-IVD), Ventana Part Number 605-100, Roche GMMI 06889565001 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 04015630972807, Lot Numbers: Y14122, Y18107