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.

1–25 of 42

  • ModerateFDA (Devices)·Z-2913-2026·2026-08-19

    Ventana Recalls navify Digital Pathology Software Due to Image Metadata Discrepancies

    Ventana Medical Systems is recalling navify Digital Pathology software versions 2.5 due to reported discrepancies between images and metadata in the viewer.

    Product
    navify Digital Pathology (on-prem) v2.5, Material Number 10092343001 navify Digital Pathology (Cloud) v2.5. Material Number 09453733001 UDI-DI Code: 761333602095AQ In the United States, navify Digital Pathology software (previously known as uPath Enterprise Software) i
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2644-2024·2024-08-28

    Medical Device Recall: Ventana Anti-CD10 Antibody May Produce False Positive Results

    Ventana Medical Systems recalls its anti-CD10 (SP67) rabbit monoclonal antibody due to potential high background and off-target staining that could produce false positive test results. Approximately 22,839 kits distributed worldwide are affected.

    Product
    Ventana anti-CD10 (SP67) Rabbit Monoclonal Primary Antibody, REF: 790-4506, IVD
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0907-2023·2023-01-18

    VENTANA PD-L1 (SP142) Assay kits recalled for light staining causing false-negative results

    Ventana Medical Systems recalled 8,927 VENTANA PD-L1 (SP142) Assay kits worldwide due to light staining that can cause false-negative immunotherapy marker test results affecting cancer treatment decisions.

    Product
    VENTANA PD-L1 (SP142) VENTANA PD-L1 (SP142) Assay (Class III, US IVD) 07709374001 VENTANA PD-L1 (SP142) Assay (CE IVD Predictive) 08008540001 VENTANA PD-L1 (SP142) IHC Assay (CE IVD Analytical) 07011571001
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1374-2022·2022-07-20

    Ventana HE 600 Automated Slide Preparer Recalled for Potential Electrical Fire Risk

    Ventana Medical Systems is recalling 763 Ventana HE 600 automated slide preparer instruments used in laboratories worldwide due to potential fluid leaks that could cause electrical shorts and fire.

    Product
    Ventana HE 600 System, automated slide preparer, for use in laboratories.
    Category
    Medical Device
    Distribution
    40 states
  • HighFDA (Devices)·Z-2262-2020·2020-06-17

    Ventana HE 600 Recalled for Electrical Short Risk

    Ventana Medical Systems is recalling 461 HE 600 instruments due to a cleaning solution leak that can cause electrical shorts and burned components.

    Product
    Model Number: 06917259001 UDI: 04015630976010 - Product Usage: The System s intended use environment includes anatomic pathology (AP) laboratories and histology facilities within hospital, clinic, reference, or private lab settings. The System is to be operated by qualified u
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-3012-2018·2018-09-26

    Ventana Recalls CINtec p16 Histology Reagent Due to Dispenser Defects

    Ventana Medical Systems is recalling 468 units of CINtec p16 Histology reagent because leaking dispensers may cause false negative test results.

    Product
    CINtec p16 Histology (250), Catalog Number 06695230001, Model 725-4713 Immunohistochemistry (IHC) for in vitro diagnostic use.
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-3006-2018·2018-09-26

    Ventana CONFIRM anti-Progesterone Receptor Antibody Recalled for Dispenser Defects

    Ventana Medical Systems is recalling CONFIRM anti-Progesterone Receptor antibodies due to leaking and sticking dispensers that may cause false negative IHC results.

    Product
    CONFIRM anti-Progesterone Receptor (PR) (1E2) Rabbit Monoclonal Primary Antibody, Catalog Number 05278392001, model 790-4296 Immunohistochemistry (IHC) for in vitro diagnostic use.
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2999-2018·2018-09-26

    Ventana Medical Systems Recalls ultraView SISH DNP Detection Kit Due to Leaking

    Ventana Medical Systems is recalling 96 units of the ultraView SISH DNP Detection Kit because leaking and sticking dispensers may cause false negative IHC results.

    Product
    ultraView SISH DNP Detection Kit US, Catalog Number 05572037001, model 760-098 Immunohistochemistry (IHC) for in vitro diagnostic use.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2996-2018·2018-09-26

    Ventana OptiView DAB IHC Detection Kit Recalled for Leaking Dispensers

    Ventana Medical Systems is recalling OptiView DAB IHC Detection Kits because leaking dispensers may cause false negative test results.

    Product
    OptiView DAB IHC Detection Kit, Catalog Number 06396500001, model 760-700 Immunohistochemistry (IHC) for in vitro diagnostic use.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2997-2018·2018-09-26

    Ventana ultraView Universal DAB Detection Kit Recalled for Dispenser Defects

    Ventana Medical Systems is recalling ultraView Universal DAB Detection Kits due to leaking and sticking reagent dispensers that may cause false negative IHC results.

    Product
    ultraView Universal DAB Detection Kit, Catalog Number 05269806001, model 760-500 Immunohistochemistry (IHC) for in vitro diagnostic use.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-3013-2018·2018-09-26

    Ventana Medical Systems Recalls Leaking CINtec p16 Histology Reagent Dispensers

    Ventana Medical Systems is recalling 240 units of CINtec p16 Histology reagent dispensers due to leaking and sticking issues that may cause false negative test results.

    Product
    CINtec p16 Histology (250) CE, Catalog Number 06695256001, model 825-4713 Immunohistochemistry (IHC) for in vitro diagnostic use.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-3016-2018·2018-09-26

    Ventana ultraView SISH DNP Detection Kit Recalled for Leaking Dispensers

    Ventana Medical Systems is recalling 342 units of the ultraView SISH DNP Detection Kit because leaking dispensers may cause false negative IHC results.

    Product
    ultraView SISH DNP Detection Kit, Catalog Number 05907136001, model 800-098 Immunohistochemistry (IHC) for in vitro diagnostic use.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-3000-2018·2018-09-26

    Ventana OptiView Amplification Kit Recalled for Leaking Dispensers

    Ventana Medical Systems is recalling OptiView Amplification Kits due to leaking dispensers that may cause false negative IHC results.

    Product
    OptiView Amplification Kit (250 test), Catalog Number 06718663001, model 860-099 Immunohistochemistry (IHC) for in vitro diagnostic use.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-3007-2018·2018-09-26

    Ventana CONFIRM anti-Estrogen Receptor Antibody Recalled for Dispenser Defects

    Ventana Medical Systems is recalling CONFIRM anti-Estrogen Receptor antibodies due to leaking and sticking dispensers that may cause false negative IHC results.

    Product
    CONFIRM anti-Estrogen Receptor (ER) (SP1) Rabbit Monoclonal Primary Antibody, Catalog Number 05278414001, Model 790-4325 Immunohistochemistry (IHC) for in vitro diagnostic use.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-3015-2018·2018-09-26

    Ventana NEXES VEN IVIEW DAB Detection Kit Recall for Leaking Dispensers

    Ventana Medical Systems is recalling NEXES VEN IVIEW DAB Detection Kits due to leaking and sticking reagent dispensers that may cause false negative IHC results.

    Product
    NEXES VEN IVIEW DAB DET KT JPN-US EXPORT, Catalog Number 05266084001 Model 760-041 Immunohistochemistry (IHC) for in vitro diagnostic use.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-3002-2018·2018-09-26

    Ventana iVIEW Blue Plus Detection Kit Recalled for Dispenser Leaks

    Ventana Medical Systems is recalling iVIEW Blue Plus Detection Kits because leaking dispensers may cause false negative IHC results.

    Product
    ISH iVIEW Blue Plus Detection Kit, Catalog Number 05266181001, model 760-097 Immunohistochemistry (IHC) for in vitro diagnostic use.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-3009-2018·2018-09-26

    Ventana Basal Cell IHC Reagent Recall Due to Dispenser Defects

    Ventana Medical Systems is recalling 75 units of Basal Cell IHC reagents due to leaking and sticking dispensers that may cause false negative results.

    Product
    VENTANA Basal Cell Cktl, (34BE12+p63)250, Catalog Number 06419445001, Model 790-1010 Immunohistochemistry (IHC) for in vitro diagnostic use.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-3003-2018·2018-09-26

    Ventana Anti-Pan Keratin Antibody Recalled for Leaking and Sticking Dispensers

    Ventana Medical Systems is recalling 354 units of Anti-Pan Keratin Primary Antibody due to leaking and sticking dispensers that may cause false negative IHC results.

    Product
    ANTI-PAN Keratin Primary Antibody, 25 mL, Catalog Number 05266840001, model 760-2135 Immunohistochemistry (IHC) for in vitro diagnostic use.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-3004-2018·2018-09-26

    Ventana ultraView Universal Alkaline Phosphatase Red Detection Kit Recalled

    Ventana Medical Systems is recalling 8,211 units of the ultraView Universal Alkaline Phosphatase Red Detection Kit due to leaking and sticking dispensers that may cause false negative IHC results.

    Product
    ultraView Universal Alkaline Phosphatase Red Detection Kit, Catalog Number 05269814001, model 760-501 Immunohistochemistry (IHC) for in vitro diagnostic use.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-3014-2018·2018-09-26

    Ventana Medical Systems Recalls Leaking HPV III Probe Dispensers

    Ventana Medical Systems is recalling 195 units of the INFORM HPV III Fam 16 Probe due to leaking and sticking dispensers that may cause false negative test results.

    Product
    INFORM HPV III Fam 16 Probe - US Export, Catalog Number 05278856001, model 800-4295 Immunohistochemistry (IHC) for in vitro diagnostic use.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-3010-2018·2018-09-26

    Ventana anti-Helicobacter Pylori Reagent Recall Due to Dispenser Leaks

    Ventana Medical Systems is recalling anti-Helicobacter Pylori reagents because leaking dispensers may cause false negative test results.

    Product
    VENTANA anti-Helicobacter Pylori (SP48) PAB 250, Catalog Number 06425623001, model 790-1015 Immunohistochemistry (IHC) for in vitro diagnostic use.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2998-2018·2018-09-26

    Ventana iView DAB Detection Kit Recalled for Leaking and Sticking Dispensers

    Ventana Medical Systems is recalling iView DAB Detection Kits due to leaking and sticking reagent dispensers that may cause false negative immunohistochemistry results.

    Product
    iView DAB Detection Kit, Catalog Number 05266157001, model 760-091 Immunohistochemistry (IHC) for in vitro diagnostic use.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-3005-2018·2018-09-26

    Ventana ISH Protease 3 Reagent Recall for Leaking and Sticking Dispensers

    Ventana Medical Systems is recalling ISH Protease 3 reagents due to leaking and sticking dispensers that may cause false negative IHC results.

    Product
    ISH Protease 3, Catalog Number 05273331001, model 780-4149 Immunohistochemistry (IHC) for in vitro diagnostic use.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-3011-2018·2018-09-26

    Ventana Recalls CINtec Histology Reagents Due to Dispenser Defects

    Ventana Medical Systems is recalling 120 units of CINtec Histology reagents worldwide because leaking dispensers may cause false negative test results.

    Product
    CINtec Histology (250), Catalog Number 06680011001, model 725-4793 Immunohistochemistry (IHC) for in vitro diagnostic use.
    Category
    Medical Device
    Distribution
    0 states

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.