The Recall Desk

Manufacturer

Ventana Medical Systems, Inc.

42 recalls in our database name Ventana Medical Systems, Inc. as the manufacturing or recalling firm.

What the numbers show

Total
42
Critical
1
Severe
9
Most recent
2026-08-19

Of the 42 recalls from Ventana Medical Systems, Inc. we have scored against our rubric, 1 (2%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 9 (21%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

26–42 of 42

  • ModerateFDA (Devices)·Z-3001-2018·2018-09-26

    Ventana iView DAB Detection Kit Recalled for Leaking and Sticking Dispensers

    Ventana Medical Systems is recalling iView DAB Detection Kits because leaking and sticking dispensers may cause false negative IHC results.

    Product
    iView DAB Detection Kit w/o Secondary Antibody, Catalog Number 05266173001, Model 760-093. For laboratory use.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-3008-2018·2018-09-26

    Ventana ISH iView Blue Detection Kit Recalled for Leaking Dispensers

    Ventana Medical Systems is recalling 559 units of the ISH iView Blue Detection Kit because the reagent dispensers may leak or stick.

    Product
    VENTANA ISH iView Blue Detection Kit, Catalog Number 05278511001, model 800-092 Immunohistochemistry (IHC) for in vitro diagnostic use.
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-0740-2018·2018-03-07

    Ventana Medical Systems Recalls NEXES VEN IVIEW DAB DET KT JPN-US EXPORT

    Ventana Medical Systems is recalling NEXES VEN IVIEW DAB DET KT JPN-US EXPORT in vitro diagnostic kits due to increased reports of leaking and sticking reagent dispensers.

    Product
    NEXES VEN IVIEW DAB DET KT JPN-US EXPORT, Ventana Part Number 760-041, Roche GMMI 05266084001 in vitro diagnostic
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0734-2018·2018-03-07

    Ventana Recalls CINtec PLUS Cytology Kit Due to Leaking Reagent Dispensers

    Ventana Medical Systems is recalling 748 units of the CINtec PLUS Cytology Kit due to increased reports of leaking and sticking reagent dispensers.

    Product
    CINtec PLUS Cytology Kit (CE-IVD), Ventana Part Number 605-100, Roche GMMI 06889565001 in vitro diagnostic
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0732-2018·2018-03-07

    Ventana ultraView SISH Detection Kit Recalled for Leaking Reagent Dispensers

    Ventana Medical Systems is recalling 6 units of the ultraView SISH Detection Kit due to increased reports of leaking and sticking reagent dispensers.

    Product
    ultraView SISH Detection Kit, Ventana Part Number 780-001, Roche GMMI 05271967001 in vitro diagnostic
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0730-2018·2018-03-07

    Ventana ultraView Universal DAB Detection Kit Recalled for Leaking Reagent Dispensers

    Ventana Medical Systems is recalling ultraView Universal DAB Detection Kits due to increased reports of leaking and sticking reagent dispensers.

    Product
    ultraView Universal DAB Detection Kit, Ventana part Number 760-500, Roche GMMI 05269806001 in vitro diagnostic
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0738-2018·2018-03-07

    Ventana Hematoxylin II and HRP Dispensers Recalled for Leaking and Sticking

    Ventana Medical Systems is recalling Hematoxylin II and specific HRP dispensers due to increased reports of leaking and sticking.

    Product
    Hematoxylin II, Ventana Part Number 790-22087, Roche GMMI 05277965001 in vitro diagnostic
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0733-2018·2018-03-07

    Ventana ultraView SISH DNP Detection Kit Recalled for Leaking Reagent Dispensers

    Ventana Medical Systems is recalling 20 units of the ultraView SISH DNP Detection Kit due to increased reports of leaking and sticking reagent dispensers.

    Product
    ultraView SISH DNP Detection Kit US, Ventana Part Number 760-098, Roche GMMI 05572037001 in vitro diagnostic
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0739-2018·2018-03-07

    Ventana ultraView SISH DNP Detection Kit Recalled for Leaking Reagent Dispensers

    Ventana Medical Systems Inc is recalling 358 units of the ultraView SISH DNP Detection Kit due to increased reports of leaking and sticking reagent dispensers.

    Product
    ultraView SISH DNP Detection Kit, Ventana Part Number 800-098, Roche GMMI 05907136001 in vitro diagnostic
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0735-2018·2018-03-07

    Ventana Recalls CINtec PLUS Cytology Kits Due to Leaking Reagent Dispensers

    Ventana Medical Systems is recalling 18 units of the CINtec PLUS Cytology Kit due to increased reports of leaking and sticking reagent dispensers.

    Product
    CINtec PLUS Cytology Kit (Canada/Japan), Ventana Part Number 805-100, Roche GMMI 06889549001 in vitro diagnostic
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0737-2018·2018-03-07

    Ventana OptiView Amplification Kit Recalled for Leaking and Sticking Reagent Dispensers

    Ventana Medical Systems is recalling OptiView Amplification Kits due to increased reports of leaking and sticking reagent dispensers.

    Product
    OptiView Amplification Kit (250 Test), Ventana Part Number 860-099, Roche GMMI 06718663001 in vitro diagnostic
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0731-2018·2018-03-07

    Ventana iView DAB IHC Detection Kit Recalled for Leaking and Sticking

    Ventana Medical Systems is recalling iView DAB IHC Detection Kits due to increased reports of leaking and sticking reagent dispensers.

    Product
    iView DAB IHC Detection Kit, Ventana part Number 760-091, Roche GMMI 05266157001 in vitro diagnostic
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0729-2018·2018-03-07

    Ventana OptiView DAB IHC Detection Kit Recalled for Leaking and Sticking

    Ventana Medical Systems is recalling OptiView DAB IHC Detection Kits due to increased reports of leaking and sticking reagent dispensers.

    Product
    OptiView DAB IHC Detection Kit, Ventana Part Number 760-700, Roche GMMI 06396500001 in vitro diagnostic
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2118-2013·2013-09-04

    Ventana BenchMark and Discovery Instruments Recalled for Heating Element Defect

    Ventana Medical Systems is recalling BenchMark and Discovery instruments because a heating element may separate, causing inconsistent staining without an error message.

    Product
    Benchmark XT/LT and Discovery XT Model Numbers: N750-BMK-FS, N750-BMKXT-FS, N750-BMKLT-FS, N750-DIS-FS, N750-DISXT-FS. Product Usage: Usage: The Benchmark product lines are intended to automatically stain histological or cytological specimens on microscope slides with spe
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0833-2013·2013-08-14

    Ventana BenchMark ULTRA Staining Platform Recalled for Fluid Overflow Risk

    Ventana Medical Systems is recalling 1,735 BenchMark ULTRA automated staining platforms due to a potential waste fluid overflow that could cause electrical shorting.

    Product
    VENTANA (a member of the Roche Group) BenchMark ULTRA; REF/MU 750-600; Research Use Only Product Usage: Research Use Only-The DISCOVERY ULTRA Advanced Staining System is intended to automatically stain histological or cytological specimens on microscope slides with specific
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0834-2013·2013-08-14

    Ventana Discovery Ultra Staining Systems Recalled for Waste Fluid Overflow Risk

    Ventana Medical Systems is recalling 54 Discovery Ultra automated staining systems because waste fluid drainage may become restricted, leading to overflow and potential fluid migration.

    Product
    VENTANA (a member of the Roche Group) DISCOVERY ULTRA; REF/MU 750-601; Research Use Only Product Usage: Research Use Only-The DISCOVERY ULTRA Advanced Staining System is intended to automatically stain histological or cytological specimens on microscope slides with specific
    Category
    Medical Device
    Distribution
    Distributed nationwide

About this company

Community-sourced company facts from Wikidata, not from any recall agency. This is background on the corporate entity — it says nothing about the recall(s) listed on this page, which come from the agency source notice above.

Ventana Medical Systems

American medical device company

Founded
1985

Official website

Source: Wikidata (Q7920223), licensed CC0. Wikidata is community-edited and may not reflect the current corporate structure.