Ventana Medical Systems Inc: Medical Device Recall in 2018 - (Recall #: Z-3013-2018)

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 p16 Histology (250) CE, Catalog Number 06695256001, model 825-4713 Immunohistochemistry (IHC) for in vitro diagnostic use.

Product Classification:

Class I

Date Initiated: August 2, 2018

Date Posted: September 26, 2018

Recall Number: Z-3013-2018

Event ID: 80807

Reason for Recall:

Leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers. A false negative IHC result may occur.

Status: Terminated

Product Quantity: 240 units

Code Information:

Lot Numbers: Y16507, Y23040, UDI: 4015630984398

Distribution Pattern:

worldwide

Voluntary or Mandated:

Voluntary: Firm initiated