Home / Recalls / Ventana Medical Systems Inc / Z-3010-2018

Z-3010-2018 Class I Terminated

Recalled by Ventana Medical Systems Inc — Oro Valley, AZ

Recall Details

Product Type
Devices
Report Date
September 26, 2018
Initiation Date
August 2, 2018
Termination Date
November 22, 2021
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
2753 units

Product Description

VENTANA anti-Helicobacter Pylori (SP48) PAB 250, Catalog Number 06425623001, model 790-1015 Immunohistochemistry (IHC) for in vitro diagnostic use.

Reason for Recall

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

Distribution Pattern

worldwide

Code Information

Lot Numbers: Y12986, Y16448, Y24119, Y16912Z, UDI: 4015630970018

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  • Z-0894-2022 Class II — BenchMark ULTRA and DISCOVERY ULTRA Instruments (January 20, 2022)
  • Z-2262-2020 Class II — Model Number: 06917259001 UDI: 04015630976010 - Product Usage: The System s (October 4, 2019)
  • Z-3012-2018 Class I — CINtec p16 Histology (250), Catalog Number 06695230001, Model 725-4713 Immunohi (August 2, 2018)
  • Z-3009-2018 Class I — VENTANA Basal Cell Cktl, (34BE12+p63)250, Catalog Number 06419445001, Model 790- (August 2, 2018)
  • Z-3006-2018 Class I — CONFIRM anti-Progesterone Receptor (PR) (1E2) Rabbit Monoclonal Primary Antibody (August 2, 2018)
  • Z-3005-2018 Class I — ISH Protease 3, Catalog Number 05273331001, model 780-4149 Immunohistochemis (August 2, 2018)
  • Z-3000-2018 Class I — OptiView Amplification Kit (250 test), Catalog Number 06718663001, model 860-099 (August 2, 2018)