NEW YORK (TheStreet) -- Shares of Trinity Biotech (TRIB - Get Report) were plummeting 49.50% to $6.56 on heavy trading volume early Tuesday afternoon after withdrawing its device application for the Meritas Troponin-I Test and Meritas Point-of-Care Analyzer with the FDA given the agency's recommendation.
The FDA had been concerned about the device's operating temperature range and inconsistencies between the Troponin-I clinical performance and the clinical performance data presented by the most recently cleared laboratory device, the Dublin-based diagnostic-products developer said in a statement.
Trinity Biotech consequently said it would cut spending to $1.5 million from $9 million a year and close a Swedish facility, resulting in 40 layoffs.
The company will spend the next nine to 12 months determining future opportunities for the platform.
About 5.39 million shares of Trinity Biotech have been traded so far today, well above the company's average trading volume of roughly 60,502 shares per day.
Separately, TheStreet Ratings team rates the stock as a "hold" with a ratings score of C.
Trinity Biotech's strengths such as its revenue growth, largely solid financial position with reasonable debt levels by most measures and reasonable valuation levels. However, as a counter to these strengths, we also find weaknesses including unimpressive growth in net income and feeble growth in the company's earnings per share.
You can view the full analysis from the report here: TRIB
TheStreet Ratings objectively rated this stock according to its "risk-adjusted" total return prospect over a 12-month investment horizon. Not based on the news in any given day, the rating may differ from Jim Cramer's view or that of this article's author.