Ventana Medical Systems Inc: Medical Device Recall in 2018 - (Recall #: Z-0735-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

CINtec PLUS Cytology Kit (Canada/Japan), Ventana Part Number 805-100, Roche GMMI 06889549001 in vitro diagnostic

Product Classification:

Class I

Date Initiated: December 19, 2017

Date Posted: March 7, 2018

Recall Number: Z-0735-2018

Event ID: 78942

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.

Status: Terminated

Product Quantity: 18 units

Code Information:

UDI 04015630976287, Lot Numbers: Y22162, Y15546

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,

Voluntary or Mandated:

Voluntary: Firm initiated