Recall Z-0350-2023— Primus Corporation dba Trinity Biotech
Class III · Terminated
Class III FDA medical device recall by Primus Corporation dba Trinity Biotech, initiated 2021-10-05, terminated 2023-08-09. It names one FDA 510(k) clearance: K952720. Product: Trinity Biotech HbA1c (GHb) Contorls Kit, 500uL (Levels I & II), REF 01-04-0020, Part number 05-01-0040B, A1c analysis. Reason: 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..
- Recalling firm
- Primus Corporation dba Trinity Biotech
- Classification
- Class III
- Status
- Terminated
- Initiated
- 2021-10-05
- Terminated
- 2023-08-09
- Firm location
- Kansas City, MO, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.