Recall Z-1336-2016— Dexcom Inc
Class I · Terminated
Class I FDA medical device recall by Dexcom Inc, initiated 2016-02-23, terminated 2017-08-11. FDA's recall record names no specific 510(k) clearance for this event. 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.. Reason: Customers may not receive an intended audible alarm or alert if relying on hearing the alarm or alert..
- Recalling firm
- Dexcom Inc
- Classification
- Class I
- Status
- Terminated
- Initiated
- 2016-02-23
- Terminated
- 2017-08-11
- Firm location
- San Diego, CA, United States
Product description
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.
Reason for recall
Customers may not receive an intended audible alarm or alert if relying on hearing the alarm or alert.
Data sourced from openFDA. This site is unofficial and independent of the FDA.