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NEW YORK ─ Luminex said on Monday that it has received a warning letter from the US Food and Drug Administration related to operations in its Austin, Texas, and Northbrook, Illinois, facilities and its Verigene Processor SP System.

In a document filed with the US Securities and Exchange Commission, the firm said that the warning letter results from inspections held at the facilities from Feb. 10, 2020 to Feb. 14, 2020, and that it pertains to FDA requirements for the Verigene SP instrument and its hybridization heater.

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