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# QS, MDR Violations at Luminex Corp.
- URL: https://www.fdaweb.com/qs-mdr-violations-at-luminex-corp/
- Published: 2020-07-07T12:00:00.000Z
- Updated: 2026-09-14T16:20:15.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5147132

A 2/10-2/14 FDA inspection at Luminex Corp., Austin, TX, found Quality System Regulation and Medical Device Reporting violations in the firm’s work as a manufacturer of microsphere-based and PCR-based multiplexing systems for in-vitro diagnostic use or life science research use, including software and hardware, reagents, and cassettes. A 6/26 [Warning Letter](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/luminex-corporation-606267-06262020?ref=fdaweb.com) says specific Quality System violations relating to the Verigene Processor SP System were: 

- failing to validate a process when changes or process deviations occurred;
- failing to adequately establish procedures for corrective and preventive action;
- failing to adequately establish procedures for performing servicing activities and verifying that servicing meets specified requirements;
- failing to adequately establish procedures to ensure that all purchased or otherwise received product and services conform to specified requirements; and
- failing to establish procedures for monitoring and control of process parameters for a validated process.

The letter says Luminex also failed to submit a written report of a correction or removal of a device initiated to reduce a risk to health posed by the device or to remedy a violation of the Federal Food, Drug, and Cosmetic Act caused by the device that may present a risk to health.

The company was told to take prompt actions to correct the violations and to respond with a list of specific steps taken to correct the violations and prevent their recurrence with documentation of each step and a timetable for completing the corrections.