ultraView Universal Alkaline Phosphatase Red Detection Kit… recallZ-3004-2018 · Ventana Medical Systems Inc · initiated Aug 2, 2018

Terminated

Is my device affected?

Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
If yours is listed, follow the instructions from Ventana Medical Systems Inc or your healthcare provider. The company's action is summarized under what the company is doing.
Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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

FDA root cause category: Under Investigation by firm

What the company is doing

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

Recall details

Recall number: Z-3004-2018
Status: Terminated
Initiated by the company: Aug 2, 2018
Posted by the FDA: Sep 14, 2018
Recalling firm: Ventana Medical Systems Inc
Quantity: 8211 units
Product code: NJT
Distribution: worldwide

Product description

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

Code information (models, lots, serial numbers)

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

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

ULTRAVIEW UNIVERSAL AP RED DETECTION KIT 05269814001
Ventana Medical Systems, Inc. · IMMUNOHISTOCHEMISTRY REAGENTS AND KITS
1 recall1 report

Other products in the same recall event

The FDA groups related products into one recall event (event 80807).

Z-2996-2018 · Terminated
OptiView DAB IHC Detection Kit, Catalog Number 06396500001, model 760-700 Immunohistochemistry (IHC) for in vitro diagnostic use.
Z-2997-2018 · Terminated
ultraView Universal DAB Detection Kit, Catalog Number 05269806001, model 760-500 Immunohistochemistry (IHC) for in vitro diagnostic use.
Z-2998-2018 · Terminated
iView DAB Detection Kit, Catalog Number 05266157001, model 760-091 Immunohistochemistry (IHC) for in vitro diagnostic use.
Z-2999-2018 · Terminated
ultraView SISH DNP Detection Kit US, Catalog Number 05572037001, model 760-098 Immunohistochemistry (IHC) for in vitro diagnostic use.
Z-3000-2018 · Terminated
OptiView Amplification Kit (250 test), Catalog Number 06718663001, model 860-099 Immunohistochemistry (IHC) for in vitro diagnostic use.
Z-3001-2018 · Terminated
iView DAB Detection Kit w/o Secondary Antibody, Catalog Number 05266173001, Model 760-093. For laboratory use.
Z-3002-2018 · Terminated
ISH iVIEW Blue Plus Detection Kit, Catalog Number 05266181001, model 760-097 Immunohistochemistry (IHC) for in vitro diagnostic use.
Z-3003-2018 · Terminated
ANTI-PAN Keratin Primary Antibody, 25 mL, Catalog Number 05266840001, model 760-2135 Immunohistochemistry (IHC) for in vitro diagnostic use.
Z-3005-2018 · Terminated
ISH Protease 3, Catalog Number 05273331001, model 780-4149 Immunohistochemistry (IHC) for in vitro diagnostic use.
Z-3006-2018 · Terminated
CONFIRM anti-Progesterone Receptor (PR) (1E2) Rabbit Monoclonal Primary Antibody, Catalog Number 05278392001, model 790-4296 Immunohistochemistry (IHC) for in vitro diagnostic …
Z-3007-2018 · Terminated
CONFIRM anti-Estrogen Receptor (ER) (SP1) Rabbit Monoclonal Primary Antibody, Catalog Number 05278414001, Model 790-4325 Immunohistochemistry (IHC) for in vitro diagnostic use…
Z-3008-2018 · Terminated
VENTANA ISH iView Blue Detection Kit, Catalog Number 05278511001, model 800-092 Immunohistochemistry (IHC) for in vitro diagnostic use.
Z-3009-2018 · Terminated
VENTANA Basal Cell Cktl, (34BE12+p63)250, Catalog Number 06419445001, Model 790-1010 Immunohistochemistry (IHC) for in vitro diagnostic use.
Z-3010-2018 · Terminated
VENTANA anti-Helicobacter Pylori (SP48) PAB 250, Catalog Number 06425623001, model 790-1015 Immunohistochemistry (IHC) for in vitro diagnostic use.
Z-3011-2018 · Terminated
CINtec Histology (250), Catalog Number 06680011001, model 725-4793 Immunohistochemistry (IHC) for in vitro diagnostic use.
Z-3013-2018 · Terminated
CINtec p16 Histology (250) CE, Catalog Number 06695256001, model 825-4713 Immunohistochemistry (IHC) for in vitro diagnostic use.

Sources and updates

Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.

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