FDA applicant

Leica Biosystems

Danvers1 decision2012–20120 recalls

FDA records 1 decision for Leica Biosystems (Danvers) in 2012: 1 original PMA approval. All are in product code MVC (System, Test, Her-2/Neu, Ihc). 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 Leica Biosystems’s devices, and how often a recall has named them.

FDA decisions per year

1in 2012

2012high 1 (2012) · low 0 (2013)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2012.

FIG. 1 — Leica Biosystems by year, 2012–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Other applicant names beginning “Leica”

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

Leica Biosystems Newcastle, Ltd. 6 Leica Biosystems Imaging, Inc. 5 Leica Microsystems (Schweiz) AG 4 Leica, Inc. 3 Leica Microsystems, Inc. 2 Leica Microsystems, Inc. O.I.D. 1 Leica Microscopy Systems, Ltd. 1 Leica Biosystems Richmond 1

Leica Biosystems

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Leica”