Primus Corporation dba Trinity Biotech FDA Recalls

2 recalls on file across devices, 0 of them Class I and 0 still open. This firm is not matched to a listed company.

Newest first

Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.

Product	Reason	Class	Initiated
A. MENARINI diagnostics Hb 9210 PREMIER, LEVEL1, LEVEL II, Hemoglobin A1c Controls for hemoglobin A1c Assay, REF 45052, Class IIIOct 5, 2021The Control Level I material value was showing results excee	The Control Level I material value was showing results exceeding the upper limit of the acceptable range after	Class IIIDevices	Oct 5, 2021
Trinity Biotech HbA1c (GHb) Contorls Kit, 500uL (Levels I & II), REF 01-04-0020, Part number 05-01-0040B, A1c analysisClass IIIOct 5, 2021The Control Level I material value was showing results excee	The Control Level I material value was showing results exceeding the upper limit of the acceptable range after	Class IIIDevices	Oct 5, 2021