Primus Corporation Dba Trinity Biotech
Country not established
- Devices
- 1
- FDA recalls
- 2
At a glance
Market reach
- United States
- FDA recalls
What Primus Corporation Dba Trinity Biotech makes
Primus Corporation Dba Trinity Biotech makes the Premier HB9210 HbA1c analyzer, a device used for measuring glycated hemoglobin in blood samples to monitor diabetes management.
The Premier HB9210 HbA1c analyzer is classified as a Class II medical device and is listed in the FDA 510(k) registry; the company is based in the United States.
Catalogue
Premier HB9210 HBA1C Analyzer Ref K112015
Regimes: 510(k) Registry: 510(k)
FDA recalls
FDA recall records list 2 recalls initiated by Primus Corporation Dba Trinity Biotech, initiated on 2021-10-05. By recorded status: 2 terminated. The reasons filed fall into these groups: other reasons as filed. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
Recalls initiated per year
- 2017 0
- 2018 0
- 2019 0
- 2020 0
- 2021 2
- 2022 0
- 2023 0
- 2024 0
- 2025 0
- 2026 0
2021
- 5 Oct 2021 Z-0349-2023 Class III Terminated 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.
- 5 Oct 2021 Z-0350-2023 Class III Terminated 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.
Frequently asked questions
How many devices does Primus Corporation Dba Trinity Biotech have in the registry?
The registry currently lists 1 device for Primus Corporation Dba Trinity Biotech. Devices recorded under merged duplicate company entries are counted once.
Which registries list Primus Corporation Dba Trinity Biotech's devices?
Among its 1 most recently registered device, Primus Corporation Dba Trinity Biotech has devices listed in FDA 510(k) (1 device).
What risk classes do Primus Corporation Dba Trinity Biotech's devices fall under?
Among its 1 most recently registered device, the classes recorded for Primus Corporation Dba Trinity Biotech's devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Primus Corporation Dba Trinity Biotech?
FDA recall records list 2 recalls initiated by Primus Corporation Dba Trinity Biotech, the most recent initiated on 5 Oct 2021. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from Primus Corporation Dba Trinity Biotech in the registry?
The most recently registered devices listed for Primus Corporation Dba Trinity Biotech include PREMIER HB9210 HBA1C ANALYZER.