Recall Z-3015-2018

Ventana Medical Systems Inc · initiated August 2, 2018

Class I Terminated

Class I – dangerous or defective products that could cause serious health problems or death

Product

NEXES VEN IVIEW DAB DET KT JPN-US EXPORT, Catalog Number 05266084001 Model 760-041 Immunohistochemistry (IHC) for in vitro diagnostic use.

Codes / lots: Lot Numbers: Y22285, Y25750. UDI: 4015630970254

Reason for recall

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

FDA-determined cause: Under Investigation by firm

Action taken

The firm disseminated their field safety notices by letter on 08/02/2018. The firm requested the destruction of the product.

Details

Recall number
Z-3015-2018
Initiated
August 2, 2018
Posted by FDA
September 14, 2018
Terminated
November 22, 2021
Product code
NJT – Immunohistochemistry Reagents And Kits
Quantity
2172 units
Distribution
worldwide
Recalling firm
Ventana Medical Systems Inc, Oro Valley, AZ

Official FDA recall record

Other products in the same recall event

RecallProductInitiated
Z-2996-2018 Class IOptiView DAB IHC Detection Kit, Catalog Number 06396500001, model 760-700…Leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers. A false negative IHC… 08/02/2018Terminated
Z-2997-2018 Class IultraView Universal DAB Detection Kit, Catalog Number 05269806001, model 760-500…Leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers. A false negative IHC… 08/02/2018Terminated
Z-2998-2018 Class IiView DAB Detection Kit, Catalog Number 05266157001, model 760-091 Immunohistochemistry…Leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers. A false negative IHC… 08/02/2018Terminated
Z-2999-2018 Class IultraView SISH DNP Detection Kit US, Catalog Number 05572037001, model 760-098…Leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers. A false negative IHC… 08/02/2018Terminated
Z-3000-2018 Class IOptiView Amplification Kit (250 test), Catalog Number 06718663001, model 860-099…Leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers. A false negative IHC… 08/02/2018Terminated
Z-3001-2018 Class IiView DAB Detection Kit w/o Secondary Antibody, Catalog Number 05266173001, Model…Leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers. A false negative IHC… 08/02/2018Terminated
Z-3002-2018 Class IISH iVIEW Blue Plus Detection Kit, Catalog Number 05266181001, model 760-097…Leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers. A false negative IHC… 08/02/2018Terminated
Z-3003-2018 Class IANTI-PAN Keratin Primary Antibody, 25 mL, Catalog Number 05266840001, model 760-2135…Leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers. A false negative IHC… 08/02/2018Terminated
Z-3004-2018 Class IultraView Universal Alkaline Phosphatase Red Detection Kit, Catalog Number 05269814001…Leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers. A false negative IHC… 08/02/2018Terminated
Z-3005-2018 Class IISH Protease 3, Catalog Number 05273331001, model 780-4149 Immunohistochemistry (IHC)…Leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers. A false negative IHC… 08/02/2018Terminated
Z-3006-2018 Class ICONFIRM anti-Progesterone Receptor (PR) (1E2) Rabbit Monoclonal Primary Antibody…Leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers. A false negative IHC… 08/02/2018Terminated
Z-3007-2018 Class ICONFIRM anti-Estrogen Receptor (ER) (SP1) Rabbit Monoclonal Primary Antibody, Catalog…Leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers. A false negative IHC… 08/02/2018Terminated
Z-3008-2018 Class IVENTANA ISH iView Blue Detection Kit, Catalog Number 05278511001, model 800-092…Leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers 08/02/2018Terminated
Z-3009-2018 Class IVENTANA Basal Cell Cktl, (34BE12+p63)250, Catalog Number 06419445001, Model 790-1010…Leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers. A false negative IHC… 08/02/2018Terminated
Z-3010-2018 Class IVENTANA anti-Helicobacter Pylori (SP48) PAB 250, Catalog Number 06425623001, model…Leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers. A false negative IHC… 08/02/2018Terminated
Z-3011-2018 Class ICINtec Histology (250), Catalog Number 06680011001, model 725-4793 Immunohistochemistry…Leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers. A false negative IHC… 08/02/2018Terminated
Z-3012-2018 Class ICINtec p16 Histology (250), Catalog Number 06695230001, Model 725-4713…Leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers. A false negative IHC… 08/02/2018Terminated
Z-3013-2018 Class ICINtec p16 Histology (250) CE, Catalog Number 06695256001, model 825-4713…Leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers. A false negative IHC… 08/02/2018Terminated
Z-3014-2018 Class IINFORM HPV III Fam 16 Probe - US Export, Catalog Number 05278856001, model 800-4295…Leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers. A false negative IHC… 08/02/2018Terminated
Z-3016-2018 Class IultraView SISH DNP Detection Kit, Catalog Number 05907136001, model 800-098…Leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers. A false negative IHC… 08/02/2018Terminated