Item 8.01. Other Events.

On June 26, 2020, Luminex Corporation (the "Company") received a warning letter (the "Warning Letter") from the U.S. Food and Drug Administration (the "FDA") relating to the operations of the Company's Austin, TX and Northbrook, IL facilities (the "Facilities") and the Company's VERIGENE Processor SP System. The Warning Letter results from inspections held at the Facilities from February 10, 2020 to February 14, 2020. The Warning Letter relates to the Company's VERIGENE SP instrument and its hybridization heater in connection with FDA requirements under the Quality System Regulation (21 C.F.R. Part 820) and the regulation of Medical Device Corrections and Removals (21 C.F.R. Part 806).

The Company takes the matters identified in the Warning Letter very seriously and intends to submit a response to FDA regarding the issues raised in the Warning Letter within 15 business days, as requested by the FDA, and to work diligently and expeditiously to resolve the issues raised by the FDA. The Warning Letter does not restrict the manufacture, production or shipment of any of the Company's products, nor require the withdrawal of any product from the marketplace. The Company believes it has already taken appropriate measures to address the items identified by the FDA with respect to the VERIGENE SP instrument and its hybridization heater, and the Company plans to include further communication of these measures in its response to the Warning Letter. In addition, the Company continues to evaluate whether further corrective or preventive action may be required.

Although the Company intends to fully respond to FDA's concerns raised in the Warning Letter, the Company cannot give any assurances that the FDA will be satisfied with its response to the Warning Letter or that such response will resolve the issues identified in the Warning Letter. Failure to promptly and fully address the issues raised in the Warning Letter to the FDA's satisfaction or to comply with U.S. medical device regulatory requirements in general could result in further regulatory and enforcement actions being initiated by the FDA. These actions could result in, among other things, product recalls, product seizures, injunctions, civil monetary penalties, delays in obtaining marketing authorization for products, an impact on federal contracts, limitations on our ability to export products, and criminal enforcement action. Any such actions could disrupt our ongoing business and operations and potentially have a material adverse effect on our business, financial condition and results of operations.

This Current Report on Form 8-K contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, that are intended to be covered by the "safe harbor" created by those sections. These forward-looking statements include the Company's intent to respond to the FDA Warning Letter in the timeframe required by the FDA, the outcome of the Company's efforts to remediate the FDA's observations, and the possible resolution of the issues identified in the Warning Letter. Forward-looking statements, which describe future plans, strategies, expectations and events, can otherwise generally be identified by the use of forward-looking terms such as "believe," "expect," "may," "will," "should," "would," "could," "seek," "intend," "plan," "goal," "project," "estimate," "anticipate" or other similar terms. These forward-looking statements are based on current beliefs, expectations and assumptions that are subject to significant risks, uncertainties and changes in circumstances that could cause actual results to differ materially from the forward-looking statements, including those risks and uncertainties discussed under the heading "Risk Factors" in the Company's Annual Report on Form 10-K, as filed with the Securities and Exchange Commission on February 27, 2020, and the Company's Quarterly Report on Form 10-Q, as filed with the Securities and Exchange Commission on May 5, 2020. You should not rely upon forward-looking statements as predictions of future events. The forward-looking statements included in this Current Report on Form 8-K speak only as of the date hereof, and except as required by law, the Company expressly disclaims any intent, obligation or undertaking to release publicly any updates or revisions to any forward-looking statements to reflect any change in the Company's expectations with regard thereto or any change in events, conditions or circumstances on which any such statements are based.

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Item 9.01. Financial Statements and Exhibits.



(d) Exhibits.

Exhibit No.               Description
                          Cover Page Interactive Data File (embedded within the Inline XBRL
104                       document).

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