31 results
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54ms
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Sources: EU EUDAMED, US FDA
Trinity Biotech USA
Manufacturer
🇺🇸 United States
Trinity Biotech USA
FDA registration
Trinity Biotech USA·41 products·🇺🇸 United States
CAPTIA NMT SYPHILIS IGM KIT
FDA Adverse Event
Malfunction
·TRINITY BIOTECH USA·Product code LIP·May 18, 2021
BARTELS ELISA LEGIONELLA URINIARY ANTIGEN
FDA Adverse Event
Malfunction
·TRINITY BIOTECH, USA·Product code MJH·November 10, 2021
CAPTIA MEASLES IGM ELISA KIT
FDA Adverse Event
Malfunction
·TRINITY BIOTECH USA·Product code PCL·March 29, 2021
CAPTIA¿ SYPHILIS (T. PALLIDUM) IGG
FDA Adverse Event
Injury
·TRINITY BIOTECH USA·Product code LIP·June 21, 2018
AMAX ThromboMAX with Calcium, 10x4ml vials. Catalog #T9902. Lyophilized extract of rabbit brain with buffer, stabilizers and calcium chloride. Responsible firm on the label: Trinity Biotech PLC, IDA Business Park, Bray, County Wicklow, Ireland. USA Enquiries - Trinity Biotech USA, 1930 Innerbelt Business Center Drive, St. Louis, MO 63114, USA.
FDA Recall
Terminated
·Trinity Biotech USA·Product code GJS·October 27, 2004
MAR DX TRINITY BIOTECH MARDX EU LYME + VLSE IGG WESTERN BLOT,
FDA Adverse Event
Injury
·MARDX DIAGNOSTICS INC./ TRINITY BIOTECH USA·Product code LSR·April 23, 2025
Bio Rad brand Autoimmune EIA ANA Screening Kit, 96 Tests, Catalog No. 96AN-BPU-TRINITY. Manufactured by: Bio-Rad Laboratories, Inc. Hercules, CA and distributed by Trinity Biotech, USA. Intended to screen for the presence of antinuclear antibodies (ANAs) in human serum as an aid in the diagnosis of certain rheumatic diseases.
FDA Recall
Terminated
·Bio-Rad Laboratories Inc·Product code LKJ·March 1, 2010
TrinityBiotech
Authorized representative
🇮🇪 Ireland·2 Manufacturers
Bartels ELISA Legionella Urinary Antigen. Model Number: B1029-440. In Vitro Diagnostic test kit for the presumptive diagnosis of past or current Legionnaires Disease.
FDA Recall
Open, Classified
·Trinity Biotech USA·Product code MJH·July 22, 2025
Bartels ELISA Legionella Urinary Antigen. Model Number: B1029-440. In Vitro Diagnostic test kit for the presumptive diagnosis of past or current Legionnaires Disease.
FDA Enforcement
Class II
·Ongoing·Trinity Biotech USA·August 20, 2025
Genesys Diluent Reagent, REF 01-03-0019 intended to be used with automated high performance liquid chromatography (HPLC) systems employing ion exchange chromatography. For in vitro diagnostic use only.
FDA Recall
Terminated
·Clark Laboratories, Inc. (dba, Trinity Biotech USA)·Product code GKA·November 1, 2018
Genesys Analytical Column, REF 01-05-0017 intended to be used with automated high performance liquid chromatography (HPLC) systems employing ion exchange chromatography. For in vitro diagnostic use only.
FDA Recall
Terminated
·Clark Laboratories, Inc. (dba, Trinity Biotech USA)·Product code GKA·November 1, 2018
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.
FDA Recall
Terminated
·Clark Laboratories, Inc. (dba, Trinity Biotech USA)·Product code GQX·May 29, 2012
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.
FDA Recall
Terminated
·Clark Laboratories, Inc. (dba, Trinity Biotech USA)·Product code GKA·November 1, 2018
Genesys 1 Reagent, REF 01-03-0020 intended to be used with automated high performance liquid chromatography (HPLC) systems employing ion exchange chromatography. For in vitro diagnostic use only.
FDA Recall
Terminated
·Clark Laboratories, Inc. (dba, Trinity Biotech USA)·Product code GKA·November 1, 2018
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 for testing of serum or plasma specimens to screen blood and/or plasma donors to exclude a history of syphilis.
FDA Recall
Terminated
·Clark Laboratories, Inc. (dba, Trinity Biotech USA)·Product code LIP·August 27, 2013
Genesys 2 Reagent, REF 01-03-0022 intended to be used with automated high performance liquid chromatography (HPLC) systems employing ion exchange chromatography. For in vitro diagnostic use only.
FDA Recall
Terminated
·Clark Laboratories, Inc. (dba, Trinity Biotech USA)·Product code GKA·November 1, 2018
Trinity Biotech Captia Measles IgM, REF/Product Code 2326060,Test Kit for 96 Determinations, IVD
FDA Recall
Terminated
·Clark Laboratories, Inc. (dba, Trinity Biotech USA)·Product code PCL·July 11, 2016