Primus Corporation dba Trinity Biotech: Medical Device Recall in 2022 - (Recall #: Z-0350-2023)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2022.

Data Source: FDA.

Product Description:

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

Product Classification:

Class III

Date Initiated: October 5, 2021

Date Posted: December 7, 2022

Recall Number: Z-0350-2023

Event ID: 91054

Reason for Recall:

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.

Status: Terminated

Product Quantity: 182 kits

Code Information:

UDI/DI 0539151674808, Lot 12161

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated