Discover your next big idea for life sciences at PACK EXPO Las Vegas
Experience a breakthrough in life sciences packaging—explore solutions from 2,300 suppliers spanning all industries, all in one place this month.

Did a Defective Medical Device Impact Clinical Trial Results?

Since the device has been recalled, agencies are now looking into trial results for this popular drug.

All eyes are on Bayer's top-selling anti-clotting drug Xarelto after European and U.S. drug regulators announced they are looking into whether or not a defective blood clotting test device affected a trial involving the product, reported Reuters.

"Due to the defect it is now thought that the INR (international normalised ratio) device may have impacted the clotting results in some patients in the warfarin group," said the European Medicines Agency, according to the published report.

The device in question measures how quickly blood starts clotting, and was recalled in December 2014 after giving falsely low test results, reported Reuters.

EMA said they plan to publish their findings.

Pharmaceutical Innovations Report
Discover the latest breakthrough packaging technologies shaping the pharmaceutical sector. This report dives into cutting-edge innovations, from smart containers that enhance patient safety to eco-friendly materials poised to transform the industry’s sustainability practices. All from PACK EXPO. Learn how forward-thinking strategies are driving efficiency and redefining what’s possible in pharma packaging.
Learn More
Pharmaceutical Innovations Report
Medical Device Innovations Report
Cutting-edge packaging technologies are transforming the medical device sector in PMMI’s “Innovation in Medical Device” report, featuring advanced materials, smart solutions, and evolving regulations. Editors share insights from nearly 300 PACK EXPO booth visits—each product deemed new and truly innovative—alongside video demonstrations of the equipment and materials on display.
Learn More
Medical Device Innovations Report