Ventana Medical Systems Inc: Medical Device Recall in 2018 - (Recall #: Z-0738-2018)

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:

Hematoxylin II, Ventana Part Number 790-22087, Roche GMMI 05277965001 in vitro diagnostic

Product Classification:

Class I

Date Initiated: December 19, 2017

Date Posted: March 7, 2018

Recall Number: Z-0738-2018

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: 71640 units

Code Information:

UDI 04015630972135, Lot Numbers: Y10759, Y17402, Y21312, Y13938, Y17403, Y22561

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