Primus Corporation dba Trinity Biotech Trinity Biotech HbA1c (GHb) Contorls Kit, 500uL (Levels I & II), REF 01-04-0020, Part number 05-01-0040B, A1c analysis Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Trinity Biotech HbA1c (GHb) Contorls Kit, 500uL (Levels I & II), REF 01-04-0020, Part number 05-01-0040B, A1c analysis
Brand
Primus Corporation dba Trinity Biotech
Lot Codes / Batch Numbers
UDI/DI 0539151674808, Lot 12161
Products Sold
UDI/DI 0539151674808, Lot 12161
Primus Corporation dba Trinity Biotech is recalling Trinity Biotech HbA1c (GHb) Contorls Kit, 500uL (Levels I & II), REF 01-04-0020, Part number 05-01-0 due to The Control Level I material value was showing results exceeding the upper limit of the acceptable range after a period of three (3) months. Addition. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
The firm sent an Urgent Filed Safety Notice their consignees on 10/05/2021 by mail. The notice explained the issue, risk and requested the destruction of of the affected devices.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026