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FDA Takes New Approach to “No Artificial Colors” Claims
FDA Takes New Approach to “No Artificial Colors” Claims
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Glucose Monitor Sensor Recall: Abbott Diabetes Care Removes Certain FreeStyle Libre 3 and FreeStyle Libre 3 Plus Sensors
Certain Abbott Diabetes Care Continuous Glucose Monitor sensors may incorrect or lower than actual glucose readings
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Detachable Coil System Recall: J&J MedTech/CERENOVUS Inc. Remove CEREPAK Detachable Coil System
MedTech/CERENOVUS is removing CEREPAK Detachable Coil Systems due to a higher than expected failure to detach rate
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Glucose Monitor Sensor Recall: Abott Diabetes Care Removes Certain FreeStyle Libre 3 and FreeStyle Libre 3 Plus Sensors
Certain Abbott Diabetes Care Continuous Glucose Monitor sensors may incorrect or lower than actual glucose readings
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Risk of False Positive Lead Test Results with Certain Capillary Blood Collection Tubes Used with Magellan Diagnostics LeadCare Testing Systems – FDA Safety Communication
FDA is alerting health care providers and lab staff of reports of false positives when using certain Micro Capillary Blood Collection tubes with the LeadCare Testing Systems.
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Early Alert: Heart Pump Issue from Abiomed
The differential pressure sensor in certain Impella devices may malfunction and cause sensor values to drift.
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FDA Launches PreCheck Pilot Program to Strengthen Domestic Pharmaceutical Manufacturing
FDA Launches PreCheck Pilot Program to Strengthen Domestic Pharmaceutical Manufacturing
http://www.fda.gov/news-events/press-announcements/fda-launches-precheck-pilot-program-strengthen-domestic-pharmaceutical-manufacturing
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Early Alert: Wound and Burn Dressing Issue from Integra LifeSciences
Integra is removing all MediHoney Wound and Burn products and certain lots of CVS Wound Gel that may have breached sterile barriers
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Early Alert: Insufflation Unit Issue from Olympus
Olympus is removing certain High Flow Insufflation Unit models due to software issues that may lead to overpressure events.
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FDA ImportShield Program Delivers Impressive Results in Strengthening FDA Oversight at U.S. Ports of Entry
FDA ImportShield Program Delivers Impressive Results in Strengthening FDA Oversight at U.S. Ports of Entry
http://www.fda.gov/news-events/press-announcements/fda-importshield-program-delivers-impressive-results-strengthening-fda-oversight-us-ports-entry
