GET TESTED INTERNATIONAL AB Fructose Intolerance Test Recalled for 8 Units (2025)
Distribution without premarket approval/clearance.
2,229 recalls tagged with “stop use immediately”.
Distribution without premarket approval/clearance.
Labeling contains claims that are not consistently present.
Distribution without premarket approval/clearance.
Labeling contains claims that are not consistently present.
Distribution without premarket approval/clearance.
Distribution without premarket approval/clearance.
Distribution without premarket approval/clearance.
Distribution without premarket approval/clearance.
Distribution without premarket approval/clearance.
Distribution without premarket approval/clearance.
Distribution without premarket approval/clearance.
Distribution without premarket approval/clearance.
Distribution without premarket approval/clearance.
Distribution without premarket approval/clearance.
Distribution without premarket approval/clearance.
Distribution without premarket approval/clearance.
Distribution without premarket approval/clearance.
A software timing and processor communication issue in MiniMed" 780G software version 6.60 may trigger Pump Error 43 and/or Pump Error 41, resulting in suspension of insulin delivery.
Potential issue where the IntelliVue monitors did not alarm.