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Home » Topics » Devices » Quality

Quality
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Monteris Medical Initiates Recall of Laser Probe Used in NeuroBiate System

July 18, 2016
Monteris Medical initiated a nationwide recall of its SideFire Select 2.2 mm Directional Laser Probe, following reports of fracture that resulted in CO2 introduction in the brain. Read More

Theranos Rescinds Two Years’ Worth of Blood-Test Results

July 18, 2016
In the ongoing Theranos saga, the company has now rescinded test results from the past two years for its Edison blood-testing diagnostics.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

Qiagen Earns Warning Letter Over TB Test Failures

July 8, 2016
The FDA issued a scathing warning letter to Germany-based Qiagen for numerous quality system failures related to its QuantiFeron TB test. Read More

Stryker Initiates Global Recall of Select Target Nano Neuro-coils

June 30, 2016
The recall was prompted by issues with substandard stretch resistance. Read More

Ethicon Voluntarily Withdraws Physiomesh

June 29, 2016
Patients already implanted with the product should be followed as usual. Read More

FDA Classifies Power Morcellation Containment Systems as Class II Devices

June 28, 2016
The systems are intended for gynecologic laparoscopies. Read More

Health Canada Finalizes IVD Guidance 18 Years After Issuing Draft

June 17, 2016
Health Canada has finalized its regulations on in vitro diagnostic labeling 18 years after issuing draft guidance. Read More

FDA Investigates Burn Risk of Zecuity Migraine Patch

June 10, 2016
The FDA is investigating the risk of serious burns and potential permanent scarring with the use of Teva’s iontophoretic transdermal patch Zecuity to treat acute migraine headaches. Read More

FDA Looks to Ban Electrical Stimulation Devices

June 10, 2016
The FDA is looking to ban electrical stimulation devices used to prevent self-injury and aggressive behavior. Read More

Nationwide Recall Issued on Laser Probe Used in NeuroBiate System

June 10, 2016
Monteris Medical initiated a nationwide recall of its SideFire Select 2.2 mm Directional Laser Probe, following reports of fracture that resulted in CO2 introduction in the brain. Read More

B. Braun to Pay $4 M to Resolve Criminal Liability Allegations

June 10, 2016
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

Avoid Repeat CAPAs With Better Risk Management Tools

June 10, 2016
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
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