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
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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