# FDA WARNING_LETTER - Primus Corporation dba Trinity Biotech - February 06, 2020

Source: https://www.keypedia.com/records/warning_letter/primus-corporation-dba-trinity-biotech/20468464-6d2d-4c66-a80d-b02394382ec7

> FDA WARNING_LETTER for Primus Corporation dba Trinity Biotech on February 06, 2020. Product: Devices. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Primus Corporation dba Trinity Biotech
- Inspection Date: 2020-02-06
- Product Type: Devices
- Office Name: Center for Devices and Radiological Health
- Summary: The FDA issued a Warning Letter to Primus Corporation dba Trinity Biotech following an inspection from January 27 to February 6, 2020, at their Kansas City, MO facility. The inspection revealed that their ultra2 Resolution Variants System, a device intended for disease diagnosis, is adulterated and misbranded.

The device is adulterated because the firm lacks an approved premarket approval (PMA) application or an investigational device exemption. It is misbranded because the firm failed to notify the FDA of its intent to introduce the device into commercial distribution via a 510(k) premarket notification. Evidence from 2018 and 2020 inspections indicates the ultra2 Resolution Variants System is a new device, created by significant changes to the previously cleared PVS99 (K955283), including modifications to the analytical column and sample analysis time, which significantly affect safety or effectiveness. Additionally, the ultra2 system claims to detect hemoglobin variants (HbS, HbC, HbE, HbD-Los Angeles) not supported by the PVS99's original 510(k) data, raising public health concerns regarding accuracy and potential for misdiagnosis. The firm continues to distribute modified columns and falsely advertises the ultra2 as "FDA cleared."

The devices are also adulterated under 21 CFR Part 820 for non-conformity with Quality System regulation. Specific violations

## Related Documents

- [483 - 2020-02-06](https://www.keypedia.com/records/483/primus-corporation-dba-trinity-biotech/21d9a69d-3de3-41ac-b392-5d1dd1719520)

## Related Officers

- [Director](https://www.keypedia.com/people/blake-bevill/7ed0dcde-28a7-452b-870d-6e085580abde)
- [Director](https://www.keypedia.com/people/timothy-t-stenzel/c53bdcbc-5f38-4c82-b8fc-181624201c10)
- [Donald St. Pierre](https://www.keypedia.com/people/donald-st-pierre/d2e2e0ca-b277-4fbb-9e1a-5c06308531ed)

Company: https://www.keypedia.com/companies/primus-corporation-dba-trinity-biotech/df325fd3-9d48-441b-a9f5-54b8401243c5

Office: https://www.keypedia.com/offices/center-for-devices-and-radiological-health/9d89aff6-e435-4764-87be-f58c01aca7f7