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Clark Laboratories, Inc. (dba,Trinity Biotech USA) Recalls
9 recalls on record · October 3, 2012 to December 26, 2018 · Medical Devices
Recalls by year
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Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
December 26, 2018Medical DevicesFDA
Clark Laboratories, Inc. (dba,Trinity Biotech USA) recalls Genesys Diluent Reagent, REF 01-03-0019 intended to be used with automated high performance liquid chromatography (HPLC)
Hazard: lack of 510K
December 26, 2018Medical DevicesFDA
Clark Laboratories, Inc. (dba,Trinity Biotech USA) recalls Genesys 2 Reagent, REF 01-03-0022 intended to be used with automated high performance liquid chromatography (HPLC) syste
Hazard: lack of 510K
December 26, 2018Medical DevicesFDA
Clark Laboratories, Inc. (dba,Trinity Biotech USA) recalls Genesys 1 Reagent, REF 01-03-0020 intended to be used with automated high performance liquid chromatography (HPLC) syste
Hazard: lack of 510K
December 26, 2018Medical DevicesFDA
Clark Laboratories, Inc. (dba,Trinity Biotech USA) recalls Genesys Analytical Column, REF 01-05-0017 intended to be used with automated high performance liquid chromatography (HPL
Hazard: lack of 510K
December 26, 2018Medical DevicesFDA
Clark Laboratories, Inc. (dba,Trinity Biotech USA) recalls ultra2 Genesys Variants Analyzer, REF 03-01-0045 intended to be used with automated high performance liquid chromatograp
Hazard: lack of 510K
September 21, 2016Medical DevicesFDA
Clark Laboratories, Inc. (dba,Trinity Biotech USA) recalls Trinity Biotech Captia Measles IgM, REF/Product Code 2326060,Test Kit for 96 Determinations, IVD
Hazard: The product lot failed to meet QC acceptance criteria during stability testing. The Calibrator OD was dropping causing the positive control to be invalid (running high out of range).
December 24, 2014Medical DevicesFDA
Clark Laboratories, Inc. (dba,Trinity Biotech USA) recalls Trinity biotech Captia (TM) Syphilis IgM Capture Test Kit, Product No./REF 800-935, Test Kit for 96 Determinations, IVD
Hazard: Through in-house routine real time stability monitoring of Trinity's Captia Syphilis IgM Capture Test Kit, Lot 033, the firm identified a failure of the kit to meet its labeled expiry dating of 6 months.
January 1, 2014Medical DevicesFDA
Clark Laboratories, Inc. (dba,Trinity Biotech USA) recalls Captia Syphilis-G Test Kit Product Usage: This is an enzyme immunoassay for the qualitative detection of IgG antibod
Hazard: Trinity Biotech recalled Trinity Biotech Captia Syphilis IgG kits due to false negative results.
October 3, 2012Medical DevicesFDA
Clark Laboratories, Inc. (dba,Trinity Biotech USA) recalls Trinity Biotech, Captia VZV IgG. Product code 2325600: 96 Tests; product code: 2325601: 480 tests. For in vitro diag
Hazard: The Positive Control for the Captia Varicella-Zoster Virus (VZV) IgG Kit has been reported as running high out of its assigned ISR range.