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 syringes in 2007, the Department of Justice announced. Read More

Having a risk tool to determine what situations require corrective and preventive actions is one strategy devicemakers can use to avoid repeat CAPAs. Read More

Renovis Surgical Technologies received a strong warning from the FDA over its failure to conform to quality system regulations covering design verification, process validation, product development requirements and risk analysis. Read More

Canada is working with Bayer to update labels and increase monitoring of its Essure birth control implant. Read More

The FDA issued a scathing warning letter to Germany-based Qiagen for numerous quality system failures related to its QuantiFeron TB test. Read More

In the ongoing Theranos saga, the company has now rescinded test results from the past two years for its Edison blood-testing diagnostics. Read More