Dexcom recalled its continuous glucose monitoring systems, which are used to monitor blood sugar levels of patients with type 1 or 2 diabetes.
The FDA noted that the audible alarm in the system might not activate when it detects hypoglycemia or hyperglycemia. If the alarm does not sound, patients could experience serious adverse events, including death.
The recall affects all model numbers and lot numbers of the following devices: Dexcom G4 PLATINUM Receiver, Dexcom G4 PLATINUM (Pediatric) Receivre, Dexcom G4 PLATINUM (Professional) Receiver, Dexcom G4 PLATINUM Receiver with Share, Dexcom G4 PLATINUM (Pediatric) Receiver with Share and the Dexcom G5 Mobile Receiver.
In the U.S., the recall includes 263,520 units that were manufactured from July 29, 2011, to March 10, 2016, and distributed from Oct. 22, 2012, to March 10, 2016.