FDA applicant

Hologic / Gen-Probe Incorporated

San Diego, CA1 decision2013–20132 recalls

FDA records 1 decision for Hologic / Gen-Probe Incorporated (San Diego, CA) in 2013: 1 510(k) clearance. All are in product code LSL (Dna-Reagents, Neisseria). Its devices cite 1 predicate, 0 of them its own earlier devices. 2 recalls are linked to its devices.

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

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

How often FDA has decided Hologic / Gen-Probe Incorporated’s devices, and how often a recall has named them.

FDA decisions per year

1in 2013

2013high 1 (2013) · low 0 (2014)2026

2026 so far, outlined.

Recalls per year

1in 2018

2013high 1 (2017) · low 0 (2013)2026

Class I Class II/III not classified

FIG. 1 — Hologic / Gen-Probe Incorporated by year, 2013–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Other applicant names beginning “Hologic”

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

Hologic, Inc. 138

Hologic / Gen-Probe Incorporated

Which product codes does it file in?

Whose devices does it build on?

What has FDA decided for it lately?

What has been recalled?

Other applicant names beginning “Hologic”