FDA applicant

Trinity Biotech (Primus Corporation, Dba Trinity Biotech)

Kansas City, MO1 decision2023–20230 recalls

FDA records 1 decision for Trinity Biotech (Primus Corporation, Dba Trinity Biotech) (Kansas City, MO) in 2023: 1 510(k) clearance. All are in product code GKA (Abnormal Hemoglobin Quantitation). Its devices cite 1 predicate, 0 of them its own earlier devices. 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, hematology panel, where it files most

How often FDA has decided Trinity Biotech (Primus Corporation, Dba Trinity Biotech)’s devices, and how often a recall has named them.

FDA decisions per year

1in 2023

2023high 1 (2023) · low 0 (2024)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2023.

FIG. 1 — Trinity Biotech (Primus Corporation, Dba Trinity Biotech) by year, 2023–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Trinity Biotech (Primus Corporation…’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Other applicant names beginning “Trinity”

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

Trinity Laboratories, Inc. 44 Trinity Biotech, Plc 12 Trinity Biotech USA 11 Trinity Orthopedics, LLC 2 Trinity Partners, LLC 1 Trinity Medical Solutions 1 Trinity Guardion 1

Trinity Biotech (Primus Corporation, Dba Trinity Biotech)

Which product codes does it file in?

Whose devices does it build on?

What has FDA decided for it lately?

Other applicant names beginning “Trinity”