Dexcom Inc recalls Dexcom G4 PLATINUM (Professional) Receiver Receiver Part Number: MT20649 Receiver (mg/dL), Black. Intended to detect t

Recalled April 20, 2016 · FDA recall Z-1336-2016 · Dexcom

Hazard

Customers may not receive an intended audible alarm or alert if relying on hearing the alarm or alert. · FDA Class I

Units

5,722

Sold at

Worldwide Distribution-US (nationwide), Canada, Italy, Netherlands, Belgium, Norway, New Zealand, Poland, Sweden, Denmark, Slovenia, Turkey, South Africa, India, Israel, Hungary, Hong Kong, UK, Ireland, France, Finland, Spain, Portugal, Colombia, Chile, Germany, Austria, Switzerland, Kuwait, United Arab Emirates, Australia, Czech Republic, Bahrain, Lebanon, and Qatar.

Description

Customers may not receive an intended audible alarm or alert if relying on hearing the alarm or alert.

Product

Dexcom G4 PLATINUM (Professional) Receiver Receiver Part Number: MT20649 Receiver (mg/dL), Black. Intended to detect trends and track glucose patterns in persons with diabetes. The G4 PLATINUM CGM System and G4 PLATINUM (Professional) CGM System use the same receiver, MT20649. The kits differ due to other kit contents, such as indications for use and professional receiver shield.

Manufacturer(s)

Dexcom Inc

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →