# FDA 483 - Luminex Corporation - January 20, 2023

Source: https://www.keypedia.com/records/483/luminex-corporation/28d8ccac-6815-4b4b-9fa0-23d265e28e06

> FDA 483 for Luminex Corporation on January 20, 2023. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Luminex Corporation
- Inspection Date: 2023-01-20
- Product Type: device
- Office Name: Chicago District Office
- Summary: An FDA inspection of Luminex Corporation in Northbrook, IL, revealed that the firm had not adequately implemented its written Medical Device Reporting (MDR) procedures. This led to multiple instances of delayed and incomplete reporting of adverse events and device malfunctions for their VERIGENE EP and BC-GN IVD medical devices. The findings indicate a significant failure in regulatory compliance regarding post-market surveillance.

## Related Documents

- [483 - 2020-02-14](https://www.keypedia.com/records/483/luminex-corporation/221264e9-df77-4e42-b781-44d51e5e60a4)
- [WARNING_LETTER - 2020-02-14](https://www.keypedia.com/records/warning_letter/luminex-corporation/02b42ede-af22-4ce1-ba03-0e0f48ac82d3)
- [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)

## Related Officers

- [Nicholas Z. Lu](https://www.keypedia.com/people/nicholas-z-lu/17448aca-e316-424c-b7b2-88c8baffc359)

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

Office: https://www.keypedia.com/offices/chicago-district-office/a510300b-0eaf-4a33-90b5-231d95977669