New packaging solutions for life sciences, all at PACK EXPO in Chicago
Discover new packaging solutions from hundreds of suppliers specializing in life sciences, all under one roof at PACK EXPO International in Chicago.

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.

New food packaging & processing solutions, all at PACK EXPO in Chicago
Experience the cutting edge of food packaging and processing innovation at PACK EXPO International this November. See machinery and equipment in action, discover new technologies, and learn sustainable solutions from experts, all in one place.
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New food packaging & processing solutions, all at PACK EXPO in Chicago
Explore new technology from hundreds of life sciences suppliers.
At PACK EXPO International, you’ll find innovations from hundreds of exhibitors that specialize in pharmaceuticals, biologics, nutraceuticals, medical devices and more. No other show delivers as many solutions to keep your products safe and effective.
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Explore new technology from hundreds of life sciences suppliers.