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Trinity Biotech USA

United States Last updated 25 Oct 2026

Devices
14
Registries
EUDAMEDFDA 510(k)GUDIDFDA
FDA recalls
21 ongoing

Catalogue14

Related companies

Authorised representatives

FDA recalls2

Device pages show only the recalls that name the device or its 510(k)/PMA.

FDA recall records list 2 recalls initiated by Trinity Biotech USA, the earliest on 2004-10-27 and the most recent on 2025-07-22. By recorded status: 1 ongoing and 1 terminated. The reasons filed fall into these groups: sterility or contamination and manufacturing or quality process. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company. Generated automatically from FDA recall records.

Generated automatically from FDA recall records, as a summary of the records listed below. It describes what the records state and is not an assessment of this manufacturer.

  • 2025

    • 22 Jul 2025 Z-2292-2025 Class II Ongoing Potential for Bartels ELISA Legionella Urinary Antigen kit B1029-440 lot 065 and 066 to contain particulate matter.

  • 2004

    • 27 Oct 2004 Z-0261-05 Unclassified (pre-2012) Terminated Prolongation of Prothrombin times in patient samples, resulting in a falsely elevated INR value.

About

Trinity Biotech plc is a public company, specialising in the development, manufacture and marketing of clinical diagnostic products. We are also a significant provider of raw materials to the life sciences industry.

From the manufacturer's own website. Source

What Trinity Biotech USA makes

Trinity Biotech USA manufactures clinical diagnostic products, specifically enzyme-linked immunosorbent assay (ELISA) and enzyme immunoassay (EIA) test systems. Their product portfolio includes diagnostic kits for detecting infectious diseases such as Chlamydia, Measles, Borrelia burgdorferi, Helicobacter pylori, HSV 1 and 2, Legionella pneumophila, Mycoplasma, and Malaria, as well as the Macra Lp(a) enzyme immunoassay kit.

The company is based in the United States and produces devices categorized as Class I, Class II, and IVD General. These products are listed in the FDA 510(k) database and EUDAMED.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Frequently asked questions

How many devices does Trinity Biotech USA have in the registry?

The registry currently lists 14 devices for Trinity Biotech USA. Devices recorded under merged duplicate company entries are counted once.

Which registries list Trinity Biotech USA's devices?

Among its 14 most recently registered devices, Trinity Biotech USA has devices listed in EUDAMED (3 devices), FDA 510(k) (11 devices) and FDA GUDID (1 device). A device can be listed in more than one registry, so these counts overlap.

What risk classes do Trinity Biotech USA's devices fall under?

Among its 14 most recently registered devices, the classes recorded for Trinity Biotech USA's devices are Class I, Class II and IVD general. Each device page shows its own class and authorisation.

Are there FDA recall records for Trinity Biotech USA?

FDA recall records list 2 recalls initiated by Trinity Biotech USA, the most recent initiated on 2025-07-22. 1 of them is recorded as ongoing. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.

What are the newest devices from Trinity Biotech USA in the registry?

The most recently registered devices listed for Trinity Biotech USA include Captia™ Cytomegalovirus IgM kit, CHLAMYDIA IGG ELISA TEST SYSTEM, CAPTIA MEASLES IGM and BORRELIA BURGDORFERI IGM ELISA TEST SYSTEM.

Generated automatically from registry data and not verified by a human reviewer.

Information

Address
2823, Girts Road, Jamestown, New York, United States
Phone
17162748653
PRRC contact
Sharon Bevan
EUDAMED SRN
US-MF-000037514
FDA FEI number
1318354