FDA applicant

Biocartis Us, Inc.

Itasca1 decision2025–20250 recalls

FDA records 1 decision for Biocartis Us, Inc. (Itasca) in 2025: 1 original PMA approval. All are in product code SFL (Nucleic Acid Based Assay, Microsatellite…). No recall is linked to its devices.

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

How often FDA has decided Biocartis Us, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2025

2025high 1 (2025)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2025.

FIG. 1 — Biocartis Us, Inc. by year, 2025–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Other applicant names beginning “Biocartis”

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

Biocartis NV 1

Biocartis Us, Inc.

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Biocartis”