FDA warns Irish medtech firm about Ultra2 product

Dublin-based Trinity Biotech vows to work with US regulator to resolve issues with its testing device

23rd August, 2020
FDA warns Irish medtech firm about  Ultra2 product
Trinity makes a number of devices that allow for speedy tests of blood for a number of diseases, including HIV, as well as other infections. Picture: iStock

Trinity Biotech has been issued with a warning about one of its products by US regulators.

The Dublin-based medical device maker, which employs about 500 people, said that the Food and Drug Administration (FDA), the US’s top medical regulator, sent the warning letter following an inspection of one of its manufacturing facilities in Kansas city, Missouri in January. The issue relates to a testing product called the Ultra2, the company said.

“Trinity Biotech is...

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