The report stated that the failure has now been positively identified as being attributable to a format change in a chemical raw material purchased from a third party supplier. This change caused instability in the product's performance, which only became apparent over a period of time, the group said.
All clinical trial sites which have received batches of the product manufactured have been discontinued, while any clinical data generated using the impacted batches is to be excluded from the trial.
'While we are disappointed at the temporary suspension of our Troponin trials, the positive is that we caught the problem early, identified the source of the problem and fixed it. The trials will recommence in mid-February and we will submit to the FDA in August 2015,' said Trinity Biotech's chief executive, Ronan O'Caoimh.
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