FDA applicant

Roche Molecular System, Inc.

Pleasanton1 decision2020–20200 recalls

FDA records 1 decision for Roche Molecular System, Inc. (Pleasanton) in 2020: 1 original PMA approval. All are in product code OWD (Somatic Gene Mutation Detection System). 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 Roche Molecular System, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2020

2020high 1 (2020) · low 0 (2021)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2020.

FIG. 1 — Roche Molecular System, Inc. by year, 2020–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Other applicant names beginning “Roche”

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

Roche Diagnostics Corp. 480 Roche Diagnostic Systems, Inc. 296 Roche Molecular Systems, Inc. 70 Roche Medical Electronics, Inc. 16 Roche Diagnostics Operations (Rdo) 14 Roche Diabetes Care, Inc. 13 Roche Analytical Instruments, Inc. 11 Roche Diagnostics Operations 9 Roche 3 Roche Diagnostics/Boehringer Mannheim GmbH 3 Roche Professional Diagnostics 2 Roche Image Analysis Systems 1

Roche Molecular System, Inc.

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Roche”