The FDA issued Grams Medical a warning letter for sterilization problems related to its reusable cannula tips. Source: The GMP Letter

The European Commission has published an updated version of harmonized standards that devicemakers and diagnostics makers can reference to ensure their products comply with relevant EU legislation. Source: The GMP…

In the ongoing Theranos saga, the company has now rescinded test results from the past two years for its Edison blood-testing diagnostics. Source: The GMP Letter

B. Braun Medical has agreed to resolve criminal liability allegations by paying $4.8 million in penalties and forfeiting an additional $4 million in restitution for selling contaminated pre-filled saline flush…

The FDA issued a scathing warning letter to Germany-based Qiagen for numerous quality system failures related to its QuantiFeron TB test. Source: The GMP Letter

Arkray is recalling certain test strips due to inaccurate blood sugar readings. Source: The GMP Letter

Sientra is planning to return all of its medical devices — including breast implant products — to the U.S. market starting March 1. Source: The GMP Letter

Dräger is recalling 117 emergency transport ventilators due to a system error that may lead to a halt in ventilation therapy. Source: The GMP Letter

Changes in the new ISO 13485 may conflict with many of the requirements in FDA’s quality system regulation. Source: The GMP Letter

The FDA has signed off on reprocessing instructions for Pentax’s ED-3490TK video duodenoscope that aim to prevent future of infections related to drug-resistant bacteria. Source: The GMP Letter