Clark Laboratories, Inc. (dba,Trinity Biotech USA)

FDA recalling firm · 5 enforcement events · 9 product records · 2012–2018 · NY

Clark Laboratories, Inc. (dba,Trinity Biotech USA) has 5 FDA enforcement events on this register (9 product records) between 2012 and 2018: 5 device; the busiest year was 2012 with 1.

0% of its events are Class I; the most common class is Class III (3). 0 events are listed as ongoing; the recalling firm's address is in NY.

Recall classification reflects the relative degree of health hazard. Event counts depend on a firm's size and product range; they are not a comparison of one firm with another.

Enforcement events

Initiated	Product (first record)	Type	Class	Records	Status
1 Nov 2018	ultra2 Genesys Variants Analyzer, REF 03-01-0045 intended to be used with automated high performance liquid chromatography (HPLC) systems employing ion exchange chromatography. For in vitro diagnostic use only.	Device	Class II	5	Terminated
11 Jul 2016	Trinity Biotech Captia Measles IgM, REF/Product Code 2326060,Test Kit for 96 Determinations, IVD	Device	Class III	1	Terminated
17 Nov 2014	Trinity biotech Captia (TM) Syphilis IgM Capture Test Kit, Product No./REF 800-935, Test Kit for 96 Determinations, IVD for In Vitro Diagnostic use; an antibody class capture enzyme immunoassay for the detection of IgM antibodies to T. pallidum as an aid to the identification of active syphilis in human serum.	Device	Class III	1	Terminated
27 Aug 2013	Captia Syphilis-G Test Kit Product Usage: This is an enzyme immunoassay for the qualitative detection of IgG antibodies to T. pallidum in serum specimens, to be used in conjunction with non-treponemal testing to provide serological evidence of infection with T. pallidum ( the agent of syphilis). It is also intended…	Device	Class II	1	Terminated
29 May 2012	Trinity Biotech, Captia VZV IgG. Product code 2325600: 96 Tests; product code: 2325601: 480 tests. For in vitro diagnostic use. Intended for the detection and quantitative determination of IgG antibody to VZV in human sera.	Device	Class III	1	Terminated

By type and class

Device5

Class III3

Class II2

Class I: 0% of this firm's events; 18% of all events on the register.

Events by year

Enforcement events for Clark Laboratories, Inc. (dba,Trinity Biotech USA) by year initiated.

Questions and answers

How many FDA recalls has Clark Laboratories, Inc. (dba,Trinity Biotech USA) had?

5 enforcement events (9 product records) on this register, 2012–2018: 5 device.

Are any Clark Laboratories, Inc. (dba,Trinity Biotech USA) recalls ongoing?

0 events are listed as ongoing in the current openFDA export.

What class are Clark Laboratories, Inc. (dba,Trinity Biotech USA) recalls?

3 Class III, 2 Class II. 0% are Class I against 18% of all events on the register. Class reflects the relative degree of health hazard of the product, not the firm.

Where does this data come from?

openFDA food, drug and device enforcement reports (CC0), export dated 28 Sep 2026.

Provenance

Source: openFDA enforcement reports (CC0), export dated 28 Sep 2026. Firm names are grouped exactly as FDA spells them; the same company can appear under several spellings. Only organisations are shown. See the methodology.