22 results
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36ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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Bartels Legionella Urinary Antigen- an adjunct to culture for the presumptive diagnosis of past or current Legionnaire's Disease by qualitative detection of Legionella Pneumophila seragroup 1 antigen in human urine. Product Code: B1029-440
FDA Recall
Terminated
·Clark Laboratories, Inc.·Product code MJH·October 11, 2021
Trinity Biotech Captia Measles IgM Kit, Catalog No. 2326060 - Product Usage: intended for the qualitative detection of Measles igM antibodies in human serum of patients suspected of measles (rubeola) infection.
FDA Recall
Terminated
·Clark Laboratories, Inc.·Product code PCL·March 17, 2021
Bartels Legionella Urinary Antigen- an adjunct to culture for the presumptive diagnosis of past or current Legionnaire's Disease by qualitative detection of Legionella Pneumophila seragroup 1 antigen in human urine. Product Code: B1029-440
FDA Enforcement
Class II
·Terminated·Clark Laboratories, Inc.·December 22, 2021
Trinity Biotech Captia Measles IgM Kit, Catalog No. 2326060 - Product Usage: intended for the qualitative detection of Measles igM antibodies in human serum of patients suspected of measles (rubeola) infection.
FDA Enforcement
Class II
·Terminated·Clark Laboratories, Inc.·May 5, 2021
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
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.
FDA Recall
Terminated
·Clark Laboratories, Inc. (dba, Trinity Biotech USA)·Product code LIP·November 17, 2014
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 Enforcement
Class II
·Terminated·Clark Laboratories, Inc. (dba,Trinity Biotech USA)·December 26, 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.
FDA Enforcement
Class II
·Terminated·Clark Laboratories, Inc. (dba,Trinity Biotech USA)·December 26, 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 Enforcement
Class II
·Terminated·Clark Laboratories, Inc. (dba,Trinity Biotech USA)·December 26, 2018
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 Enforcement
Class II
·Terminated·Clark Laboratories, Inc. (dba,Trinity Biotech USA)·December 26, 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 Enforcement
Class II
·Terminated·Clark Laboratories, Inc. (dba,Trinity Biotech USA)·December 26, 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 Enforcement
Class III
·Terminated·Clark Laboratories, Inc. (dba,Trinity Biotech USA)·October 3, 2012
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 Enforcement
Class II
·Terminated·Clark Laboratories, Inc. (dba,Trinity Biotech USA)·January 1, 2014