Primus Corporation dba Trinity Biotech recalls A. MENARINI diagnostics Hb 9210 PREMIER, LEVEL1, LEVEL II, Hemoglobin A1c Controls for hemoglobin A1c Assay, REF 45052,…

Recall date

October 5, 2021

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0349-2023

FDA classification

Class III

Brand / firm

Primus Corporation dba Trinity Biotech

Sold / distributed

Turkey, India, Romania, Thailand, Vietnam, S. Korea, Peru, Pakistan Austria, UAE, Chile, Italy.

Why it was recalled

The Control Level I material value was showing results exceeding the upper limit of the acceptable range after a period of three (3) months. The unacceptable Control Level 1 value results in the Analyzer generating an error code which stops further testing and nullifies associated patient samples, resulting in a delay in patient results and a potential delay in therapeutic modifications.

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

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