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VENTANA PDL1 SP142 ASSAY 50testsRecalls & reported problems

Ventana Medical Systems, Inc. · Class 3

Data updated Oct 18, 2026 from official FDA records · Editorial policy

1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.

Adverse event reports
0
Deaths reported
0
Injuries reported
0
Recalls naming it
1

Summary

No MAUDE adverse event reports in our data reference this device identifier directly.

1 FDA recall record name this device's identifier, 1 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

  1. Nov 18, 2022Class IIOpen, Classified

    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.

    Z-0907-2023 · Root cause: Process design · Recall details · FDA record ↗

Other Immunohistochemistry assay, antibody, programmed death-ligand 1 devices

All Immunohistochemistry assay, antibody, programmed death-ligand 1 devices →

Sources and updates

How reports and recalls are matched · Editorial policy · Report an error on this page