Ventana Medical Systems recalls

5 official recalls and safety alerts involving Ventana Medical Systems since 2022-04, from FDA · Device. Newest first. Check the official notice for exact models and batch codes.

This list only includes recalls Recall Atlas has collected since 2021-10. A product not listed here may still be affected; check with Ventana Medical Systems or the relevant agency.

1. 2026-08-19
2. US
   Drugs & medicalClass II

   Ventana Medical Systems, Inc. recalls navify Digital Pathology (on-prem) v2.5, Material Number 10092343001 navify Digital Pathology (Cloud) v2.5. Material Number…

   Due to complaints received for the Image Management System regarding image/metadata discrepancy with the Viewer window

   FDA · DeviceVentana Medical Systems, Inc.Worldwide - U.S. Nationwide distribution including in the states of AL, AR,…Official notice →
3. 2024-08-28
4. US
   Drugs & medicalClass II

   Ventana Medical Systems, Inc. recalls Ventana anti-CD10 (SP67) Rabbit Monoclonal Primary Antibody, REF: 790-4506, IVD

   Their is a potential for high background and off-target staining when using the monoclonal primary antibody which can result in false positive results.

   FDA · DeviceVentana Medical Systems, Inc.Worldwide - US Nationwide distribution including in the states of AK, AL, AR,…Official notice →
5. 2023-01-18
6. US
   Drugs & medicalClass II

   Ventana Medical Systems, Inc. recalls VENTANA PD-L1 (SP142) VENTANA PD-L1 (SP142) Assay (Class III, US IVD) 07709374001 VENTANA PD-L1 (SP142) Assay (CE IVD Predictive)…

   Internal comparison studies revealed unacceptable, light staining. Light staining affects the borderline of positive versus negative test results. It can cause a reduction in both staining intensity and the percent…

   FDA · DeviceVentana Medical Systems, Inc.Worldwide distribution - U.S. Nationwide distribution including in the states…Official notice →
7. 2022-07-20
8. US
   Drugs & medicalClass II

   Ventana Medical Systems Inc recalls Ventana HE 600 System, automated slide preparer, for use in laboratories.

   There is a potential for fluid leak inside the Ventana HE 600 instrument which could result in electrical short and fire

   FDA · DeviceVentana Medical Systems IncUS: AL AR AZ CA CO CT DC FL GA HI IA IL IN KS KY MA MD MI MN MO MS MT NC NE NJ…Official notice →
9. 2022-04-13
10. US
    Drugs & medicalClass II

    Ventana Medical Systems Inc recalls BenchMark ULTRA and DISCOVERY ULTRA Instruments

    Potential for Fluid Leak inside a staining system that could cause an electrical short circuit of the General Purpose Input/ Output Board's J1 Connector that could result in smoke and fire.

    FDA · DeviceVentana Medical Systems IncUS: CA, IL, PA, FL, AZ, NY, OH, CO, AR, NC, MD, AL, AK, LA, IA, MN, MA, ND,…Official notice →