FDA applicant

Ventana Medical Systems, Inc. (Roche Tissue Diagnostics)

Tucson3 decisions2021–20260 recalls

FDA records 3 decisions for Ventana Medical Systems, Inc. (Roche Tissue Diagnostics) (Tucson) from 2021 to 2026: 3 original PMA approvals. Most are in product codes QNH (Immunohistochemistry Test, Dna Mismatch Repair…) and SER (Immunohistochemistry Assay, Antibody, Met). No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, pathology panel, where it files most

How often FDA has decided Ventana Medical Systems, Inc. (Roche Tissue Diagnostics)’s devices, and how often a recall has named them.

FDA decisions per year

1in 2025

2021high 1 (2021) · low 0 (2022)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2021.

FIG. 1 — Ventana Medical Systems, Inc. (Roche Tissue Diagnostics) by year, 2021–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Ventana Medical Systems, Inc. (Roche…’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Other applicant names beginning “Ventana”

FDA records each applicant name separately; these may or may not be the same firm.

Ventana Medical Systems, Inc. 62 Ventana, Inc. 1 Ventana Medical Sytems, Inc. 1

Ventana Medical Systems, Inc. (Roche Tissue Diagnostics)

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Ventana”