9 results
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86ms
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Sources: EU EUDAMED, US FDA
Trinity Biotech (Primus Corporation dba Trinity Biotech)
Manufacturer
🇺🇸 United States
Trinity Biotech (Primus Corporation dba Trinity Biotech)
FDA registration
Trinity Biotech (Primus Corporation dba Trinity Biotech)·3 products·🇺🇸 United States
PREMIER HB9210
FDA Adverse Event
Malfunction
·TRINITY BIOTECH (PRIMUS CORPORATION DBA TRINITY BIOTECH)·Product code LCP·April 14, 2026
TrinityBiotech
Authorized representative
🇮🇪 Ireland·2 Manufacturers
A. MENARINI diagnostics Hb 9210 PREMIER, LEVEL1, LEVEL II, Hemoglobin A1c Controls for hemoglobin A1c Assay, REF 45052, part number 05-01-0926, A1c analysis
FDA Recall
Terminated
·Primus Corporation dba Trinity Biotech·Product code JPK·October 5, 2021
Trinity Biotech HbA1c (GHb) Contorls Kit, 500uL (Levels I & II), REF 01-04-0020, Part number 05-01-0040B, A1c analysis
FDA Recall
Terminated
·Primus Corporation dba Trinity Biotech·Product code JPK·October 5, 2021
A. MENARINI diagnostics Hb 9210 PREMIER, LEVEL1, LEVEL II, Hemoglobin A1c Controls for hemoglobin A1c Assay, REF 45052, part number 05-01-0926, A1c analysis
FDA Enforcement
Class III
·Terminated·Primus Corporation dba Trinity Biotech·December 7, 2022
Trinity Biotech HbA1c (GHb) Contorls Kit, 500uL (Levels I & II), REF 01-04-0020, Part number 05-01-0040B, A1c analysis
FDA Enforcement
Class III
·Terminated·Primus Corporation dba Trinity Biotech·December 7, 2022
Emergo Europe B.V.
Authorized representative
🇳🇱 Netherlands·900 Manufacturers·22100 Devices