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All product recalls associated with Ventana Medical Systems, Inc..
Total Recalls
4
Past Year
0
Class I (Serious)
0
Most Recent
Jun 2024
Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.
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 intensity and the percent positivity, which could potentially lead to a false-negative PD-L1 result.
There is a potential for fluid leak inside the Ventana HE 600 instrument which could result in electrical short and fire