Trinity Biotech HbA1c — Class III medical device recall Z-0350-2023
Terminated recall by Primus Corporation dba Trinity Biotech, reported 2022-12-07. The Control Level I material value was showing results exceeding the upper limit of the acceptable range after
| Recall number | Z-0350-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Primus Corporation dba Trinity Biotech, Kansas City, MO, United States |
| Recall initiated | 2021-10-05 |
| Classified | 2022-12-01 |
| Reported by FDA | 2022-12-07 |
| Terminated | 2023-08-09 |
| Countries outside the US | AE, AT, CL, IN, IT, KR, PE, PK, RO, TH, TR, VN |
| Quantity | 182 kits |
| Lot numbers | 12161 |
| Model numbers | 01-04-0020, 05-01-0040B, A1C |
Product
Trinity Biotech HbA1c (GHb) Contorls Kit, 500uL (Levels I & II), REF 01-04-0020, Part number 05-01-0040B, A1c analysis
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0350-2023. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.