Recall Z-0349-2023— 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: A. MENARINI diagnostics Hb 9210 PREMIER, LEVEL1, LEVEL II, Hemoglobin A1c Controls for hemoglobin A1c Assay, REF 45052, part number 05-01-0926, 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. 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
A. MENARINI diagnostics Hb 9210 PREMIER, LEVEL1, LEVEL II, Hemoglobin A1c Controls for hemoglobin A1c Assay, REF 45052, part number 05-01-0926, 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. 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.