# FDA 483 - Luminex Corporation - January 13, 2023

Source: https://www.globalkeysolutions.net/records/483/luminex-corporation/a1afb9d1-45bc-478f-970a-0046a41f2778

> FDA 483 for Luminex Corporation on January 13, 2023. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Luminex Corporation
- Inspection Date: 2023-01-13
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - West III
- Summary: Luminex Corporation, a medical device manufacturer in Austin, TX, was cited for three significant issues during an FDA inspection. The firm failed to adequately revalidate processes after changes or deviations, including a VERIGENE Processor SP verification method and ARIES assay cassette manufacturing, which led to a Class III recall. Additionally, the company's corrective and preventive action procedures were found inadequate, a repeat observation, and several Medical Device Reports for AIRES SARS-CoV-2 Assay malfunctions were not submitted within the required 30-day timeframe, potentially delaying diagnoses and risking patient health.

## Related Officers

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

Company: https://www.globalkeysolutions.net/companies/luminex-corporation/89e2a70e-d1fc-4c47-b6a0-5ccfff829ecb

Office: https://www.globalkeysolutions.net/offices/division-of-human-and-animal-food-operations-west-iii/2cda09a5-06c4-433f-9df0-0d7903a6efab