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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Critical RiskFDA Device

Ventana Medical Systems Inc: Leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers. A false negative IHC result may occur.; Leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers

Agency Publication Date: September 14, 2018
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Affected Products

Product: OptiView DAB IHC Detection Kit, Catalog Number 06396500001, model 760-700 Immunohistochemistry (IHC) for in vitro diagnostic use.

Lot Numbers: Y25760, E00119, Y24225, UDI: 4015630984039

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Product: ultraView Universal DAB Detection Kit, Catalog Number 05269806001, model 760-500 Immunohistochemistry (IHC) for in vitro diagnostic use.

Lot Numbers: Y25695, Y22147, UDI: 4015630972173

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Product: iView DAB Detection Kit, Catalog Number 05266157001, model 760-091 Immunohistochemistry (IHC) for in vitro diagnostic use.

Lot Number: Y24245, UDI: 4015630971749

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Product: ultraView SISH DNP Detection Kit US, Catalog Number 05572037001, model 760-098 Immunohistochemistry (IHC) for in vitro diagnostic use.

Lot Number: Y24347, UDI: 4015630970384

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Product: OptiView Amplification Kit (250 test), Catalog Number 06718663001, model 860-099 Immunohistochemistry (IHC) for in vitro diagnostic use.

Lot Number: Y26282, UDI: 4015630984749

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Product: iView DAB Detection Kit w/o Secondary Antibody, Catalog Number 05266173001, Model 760-093. For laboratory use.

Lot Number: Y19981, UDI: 4015630970261

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Product: ISH iVIEW Blue Plus Detection Kit, Catalog Number 05266181001, model 760-097 Immunohistochemistry (IHC) for in vitro diagnostic use.

Lot Numbers: Y15410, Y24365 UDI: 4015630972029

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Product: ANTI-PAN Keratin Primary Antibody, 25 mL, Catalog Number 05266840001, model 760-2135 Immunohistochemistry (IHC) for in vitro diagnostic use.

Lot Number: Y21610, UDI: 4015630971572

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Product: ultraView Universal Alkaline Phosphatase Red Detection Kit, Catalog Number 05269814001, model 760-501 Immunohistochemistry (IHC) for in vitro diagnostic use.

Lot Numbers: Y15071, Y18053, Y22469, UDI: 4015630972258

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Product: ISH Protease 3, Catalog Number 05273331001, model 780-4149 Immunohistochemistry (IHC) for in vitro diagnostic use.

Lot Numbers: Y13927, Y18872, Y22569, Y25883, UDI: 4015630971886

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Product: CONFIRM anti-Progesterone Receptor (PR) (1E2) Rabbit Monoclonal Primary Antibody, Catalog Number 05278392001, model 790-4296 Immunohistochemistry (IHC) for in vitro diagnostic use.

Lot Numbers: Y12992, Y18852, Y23051, UDI: 4015630972203

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Product: CONFIRM anti-Estrogen Receptor (ER) (SP1) Rabbit Monoclonal Primary Antibody, Catalog Number 05278414001, Model 790-4325 Immunohistochemistry (IHC) for in vitro diagnostic use.

Lot Numbers: Y18586, Y24472, UDI: 4015630972234

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Product: VENTANA ISH iView Blue Detection Kit, Catalog Number 05278511001, model 800-092 Immunohistochemistry (IHC) for in vitro diagnostic use.

Lot Numbers: Y15105, Y22455, UDI: 4015630971930

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Product: VENTANA Basal Cell Cktl, (34BE12+p63)250, Catalog Number 06419445001, Model 790-1010 Immunohistochemistry (IHC) for in vitro diagnostic use.

Lot Number: Y20881, UDI: 4015630984534

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

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

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Product: CINtec Histology (250), Catalog Number 06680011001, model 725-4793 Immunohistochemistry (IHC) for in vitro diagnostic use.

Lot Number: Y23135, UDI: 4015630970476

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Product: CINtec p16 Histology (250), Catalog Number 06695230001, Model 725-4713 Immunohistochemistry (IHC) for in vitro diagnostic use.

Lot Numbers: Y13547, Y19158, UDI: 4015630970469

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

Lot Numbers: Y16507, Y23040, UDI: 4015630984398

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Product: INFORM HPV III Fam 16 Probe - US Export, Catalog Number 05278856001, model 800-4295 Immunohistochemistry (IHC) for in vitro diagnostic use.

Lot Number: Y19417, UDI: 4015630972210

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

Lot Numbers: Y22285, Y25750. UDI: 4015630970254

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Product: ultraView SISH DNP Detection Kit, Catalog Number 05907136001, model 800-098 Immunohistochemistry (IHC) for in vitro diagnostic use.

Lot Number: Y26299, UDI: 4015630972500

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Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 80807
Status: Resolved
Manufacturer: Ventana Medical Systems Inc
Manufactured In: United States
Units Affected: 21 products (11,712 units; 14,655 units; 3068 units; 96 units; 461 units; 10 units; 2136 units; 354 units; 8211 units; 2231 units; 1655 units; 1719 units; 559 units; 75 units; 2753 units; 120 units; 468 units; 240 units; 195 units; 2172 units; 342 units)

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.