rss – PRAIS 2.0

FDA Intends to Take Action Against Non-FDA-Approved GLP-1 Drugs

Murilo Freitas - 21:43, 5 de February de 202685

FDA Intends to Take Action Against Non-FDA-Approved GLP-1 Drugs
http://www.fda.gov/news-events/press-announcements/fda-intends-take-action-against-non-fda-approved-glp-1-drugs

rss

Trividia Health, Inc. Initiates Labeling Correction for all TRUE METRIX® Blood Glucose Monitoring Systems

Murilo Freitas - 05:00, 5 de February de 202654

FT. LAUDERDALE, FL) – February 6, 2026 – Trividia Health, Inc., announced today that it is initiating a labeling correction which requires a modification of the Owner’s Booklets/System Instructions for Use for all TRUE METRIX, TRUE METRIX AIR, TRUE METRIX GO, and TRUE METRIX PRO Blood Glucose Monit

http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/trividia-health-inc-initiates-labeling-correction-all-true-metrixr-blood-glucose-monitoring-systems

rss

FDA Takes New Approach to “No Artificial Colors” Claims

Murilo Freitas - 14:07, 4 de February de 202630

FDA Takes New Approach to “No Artificial Colors” Claims

http://www.fda.gov/news-events/press-announcements/fda-takes-new-approach-no-artificial-colors-claims

rss

Glucose Monitor Sensor Recall: Abbott Diabetes Care Removes Certain FreeStyle Libre 3 and FreeStyle Libre 3 Plus Sensors

Murilo Freitas - 05:00, 4 de February de 202629

Certain Abbott Diabetes Care Continuous Glucose Monitor sensors may incorrect or lower than actual glucose readings

http://www.fda.gov/medical-devices/medical-device-recalls-and-early-alerts/glucose-monitor-sensor-recall-abbott-diabetes-care-removes-certain-freestyle-libre-3-and-freestyle

rss

Detachable Coil System Recall: J&J MedTech/CERENOVUS Inc. Remove CEREPAK Detachable Coil System

Murilo Freitas - 05:00, 4 de February de 202693

MedTech/CERENOVUS is removing CEREPAK Detachable Coil Systems due to a higher than expected failure to detach rate

http://www.fda.gov/medical-devices/medical-device-recalls-and-early-alerts/detachable-coil-system-recall-jj-medtechcerenovus-inc-remove-cerepak-detachable-coil-system

rss

Glucose Monitor Sensor Recall: Abott Diabetes Care Removes Certain FreeStyle Libre 3 and FreeStyle Libre 3 Plus Sensors

Murilo Freitas - 05:00, 3 de February de 202644

Certain Abbott Diabetes Care Continuous Glucose Monitor sensors may incorrect or lower than actual glucose readings

http://www.fda.gov/medical-devices/medical-device-recalls-and-early-alerts/glucose-monitor-sensor-recall-abott-diabetes-care-removes-certain-freestyle-libre-3-and-freestyle

rss

Risk of False Positive Lead Test Results with Certain Capillary Blood Collection Tubes Used with Magellan Diagnostics LeadCare Testing Systems – FDA Safety Communication

Murilo Freitas - 17:00, 2 de February de 2026375

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.

http://www.fda.gov/medical-devices/safety-communications/risk-false-positive-lead-test-results-certain-capillary-blood-collection-tubes-used-magellan

rss