Primus Corporation dba Trinity Biotech recalls Trinity Biotech HbA1c (GHb) Contorls Kit, 500uL (Levels I & II), REF 01-04-0020, Part number 05-01-0040B, A1c analysis

Recall date

October 5, 2021

Source

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

Recall number

Z-0350-2023

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. Additionally, per the firm, 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

Trinity Biotech HbA1c (GHb) Contorls Kit, 500uL (Levels I & II), REF 01-04-0020, Part number 05-01-0040B, A1c analysis