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Luminex Corporation MARCS-CMS 606267 —

Delivery Method:
VIA Electronic Mail
Medical Devices

Recipient Name
Carlo Rosa
Recipient Title
Luminex Corporation

13040 Saluggia VC

Issuing Office:
Division of Medical Device and Radiological Health Operations West

United States

Dear Mr. Rosa:

The Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our Warning Letter (WL #606267) dated June 26, 2020, that was issued to Luminex Corporation located at 12112 Technology Blvd., Austin, TX and 4088 Commercial Ave., Northbrook, IL, after it was acquired by DiaSorin S.P.A. on 7/14/2021. Based on our evaluation, it appears that you have addressed the violation(s) contained in this Warning Letter. Future FDA inspections and regulatory activities will further assess the adequacy and sustainability of these corrections.

This letter does not relieve you or your firm from the responsibility of taking all necessary steps to assure sustained compliance with the Federal Food, Drug, and Cosmetic Act and its implementing regulations or with other relevant legal authority. The Agency expects you and your firm to maintain compliance and will continue to monitor your state of compliance. This letter will not preclude any future regulatory action should violations be observed during a subsequent inspection or through other means.

Jessica Mu
Director, Compliance Branch
Office of Medical Device and Radiological Health Operations
Division 3

Cc: Angelo Rago, President, arago@luminexcorp.com
      Brian Levandowski, VP Manufacturing MDX, blevandowski@luminexcorp.com

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