The US Food and Drug Administration had raised concerns over the Troponin detector device’s temperature range and consistency of its performance compared to laboratory devices.
Trinity said it believed its devices all operated consistently well and better than other point-of-care Troponin products currently available, but as there was no guarantee it could match a lab-based system it was withdrawing them.
The group will close its Uppsala facility in Sweden and move it to Bray in Ireland, which will reduce its cost base to US$1.5mln from US$9mln
Its next accounts will also include a US$50mln write-off.
“Over the coming weeks we will engage with the FDA to gain a better understanding of the nature of their concerns,” said Trinity.
Shares fell 52% to US$6.26.
Story by ProactiveInvestors