Home / Recalls / Ventana Medical Systems Inc / Z-2997-2018

Z-2997-2018 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
14,655 units

Product Description

ultraView Universal DAB Detection Kit, Catalog Number 05269806001, model 760-500 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: Y25695, Y22147, UDI: 4015630972173

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  • Z-3005-2018 Class I — ISH Protease 3, Catalog Number 05273331001, model 780-4149 Immunohistochemis (August 2, 2018)
  • Z-3016-2018 Class I — ultraView SISH DNP Detection Kit, Catalog Number 05907136001, model 800-098 Imm (August 2, 2018)
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  • Z-3015-2018 Class I — NEXES VEN IVIEW DAB DET KT JPN-US EXPORT, Catalog Number 05266084001 Model 760-0 (August 2, 2018)
  • Z-3001-2018 Class I — iView DAB Detection Kit w/o Secondary Antibody, Catalog Number 05266173001, Mode (August 2, 2018)