Ventana Medical Systems navify Digital Pathology (on-prem) v2.5, Material Number 10092343001 recall — FDA Z-2913-2026
Due to complaints received for the Image Management System regarding image/metadata discrepancy with the Viewer window
Overview of recall records associated with Ventana Medical Systems, Inc., including dates, categories and classifications where available.
Classification mix: Class II: 5.
Due to complaints received for the Image Management System regarding image/metadata discrepancy with the Viewer window
Their is a potential for high background and off-target staining when using the monoclonal primary antibody which can result in false positive results.
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…
There is a potential for fluid leak inside the Ventana HE 600 instrument which could result in electrical short and fire
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.
This page summarizes recall records in which the official source identifies Ventana Medical Systems, Inc. as the recalling firm or manufacturer. The number of records should not be treated as a safety rating or a measure of company size, because recall counts depend on product mix, reporting periods and how government records are organized.
Compare the dates, categories and classifications together rather than relying on the total alone. Open an individual record for the recalled product, reason, distribution details and current instructions available from the source.