6 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Status: Terminated
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Ultra2 Resolution Variants System for Abnormal Hemoglobin Quantitation
FDA Recall
Terminated
·Primus Corporation·Product code GKA·October 9, 2020
Ultra2 Resolution Variants System for Abnormal Hemoglobin Quantitation
FDA Enforcement
Class II
·Terminated·Primus Corporation·November 11, 2020
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