Current Newsletter: October 2016 (PDF - 244 KB)
Articles available within the current newsletter:
- In Brief - Recalls and Safety Alerts
- Medical Device Innovation Consortium (MDIC) Case for Quality Forum
- MedSun Survey Final Report - Mobile Medical Carts
- Highlighted Reports
- Links to FDA/CDRH Databases and Other Information Sources
Recalls and Safety Alerts:
GlucaGen HypoKit (glucagon [rDNA origin] for injection) by Novo Nordisk Inc: Recall
Recall of six batches due to two customer complaints from the UK and Portugal involving detached needles on the syringe with sterile water for injection...
GlucaGen HypoKit (glucagon [rDNA origin] for injection) by Novo Nordisk Inc: Recall
Recall of six batches due to two customer complaints from the UK and Portugal involving detached needles on the syringe with sterile water for injection...
Ovarian Cancer Screening Tests: Safety Communication - FDA Recommends Against Use
The FDA is alerting women about the risks associated with the use of tests being marketed as ovarian cancer screening tests.Despite extensive research and published studies, there are currently no screening tests for ovarian cancer that are sensitive enough to reliably screen for ovarian cancer without a high number of inaccurate results...
The FDA is alerting women about the risks associated with the use of tests being marketed as ovarian cancer screening tests.Despite extensive research and published studies, there are currently no screening tests for ovarian cancer that are sensitive enough to reliably screen for ovarian cancer without a high number of inaccurate results...
Mass Spectrometers by Sciex: Safety Communication - Incorrect Assignment of Test Results
The FDA is alerting lab staff and health care professionals about a software defect that may cause the devices to incorrectly assign results to samples analyzed...
The FDA is alerting lab staff and health care professionals about a software defect that may cause the devices to incorrectly assign results to samples analyzed...
Vascu-Guard Peripheral Vascular Patch by Baxter International: Letter to Health Care Providers
The FDA is concerned that the Vascu-Guard patch may not be performing as intended and that patients who are treated with the product may be at risk for serious adverse health consequences...
The FDA is concerned that the Vascu-Guard patch may not be performing as intended and that patients who are treated with the product may be at risk for serious adverse health consequences...
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