# FDA WARNING_LETTER - Luminex Corporation - February 14, 2020

Source: https://www.keypedia.com/records/warning_letter/luminex-corporation/02b42ede-af22-4ce1-ba03-0e0f48ac82d3

> FDA WARNING_LETTER for Luminex Corporation on February 14, 2020. Product: Devices. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Luminex Corporation
- Inspection Date: 2020-02-14
- Product Type: Devices
- Office Name: Division of Medical Device and Radiological Health Operations East
- Summary: The FDA issued a Warning Letter to Luminex Corporation following inspections from February 10-14, 2020, at their Austin, TX, and Northbrook, IL facilities. The inspections revealed that Luminex's VERIGENE Processor SP System is adulterated under 21 U.S.C. § 351(h) due to non-conformity with Quality System (QS) regulation (21 CFR Part 820) and misbranded under 21 U.S.C. § 352(t)(2) for failing to report corrections or removals.

Key violations include:
1.  **Failure to validate processes (21 CFR § 820.75(c)):** Luminex used heater fixtures from a new manufacturer for VERIGENE SP calibration since March 2019 without adequate validation, an approved plan, or a report, and without validating the new QC method.
2.  **Inadequate CAPA procedures (21 CFR § 820.100(a)):** CAPA LMNX-CAPA-18-017, opened for false negative results with VERIGENE heat calibration fixtures, failed to document containment actions for distributed instruments serviced with inadequately validated fixtures.
3.  **Inadequate servicing procedures (21 CFR § 820.200(a)):

## Related Documents

- [483 - 2020-02-14](https://www.keypedia.com/records/483/luminex-corporation/221264e9-df77-4e42-b781-44d51e5e60a4)
- [483 - 2021-10-22](https://www.keypedia.com/records/483/luminex-corporation/269aaf2d-c120-43cc-a6a8-ed91fe724725)
- [EIR - 2023-01-20](https://www.keypedia.com/records/eir/luminex-corporation/da1d5c99-6d34-4f55-9d5f-57544e9bef7a)
- [483 - 2023-01-20](https://www.keypedia.com/records/483/luminex-corporation/28d8ccac-6815-4b4b-9fa0-23d265e28e06)

## Related Officers

- [Steve Beck](https://www.keypedia.com/people/steve-beck/58509578-e079-4ae6-8fa0-40e35593b612)
- [Program Division Director](https://www.keypedia.com/people/shari-j-shambaugh/aaea1185-eca8-41f8-bec7-d5d0024b582d)
- [Director](https://www.keypedia.com/people/timothy-t-stenzel/c53bdcbc-5f38-4c82-b8fc-181624201c10)

Company: https://www.keypedia.com/companies/luminex-corporation/55525767-0124-4f84-8e09-0a8d7b03947e

Office: https://www.keypedia.com/offices/division-of-medical-device-and-radiological-health-operations-east/360ecccc-5273-4159-86e7-9eaeb8d41456