BEUDAMED
    FDA Enforcement Class I Terminated

    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.

    Recall: Z-1336-2016 · Reported April 20, 2016

    Enforcement

    Recall Number
    Z-1336-2016
    Event ID
    73412
    Classification
    Class I
    Status
    Terminated
    Product Type
    Devices
    Firm
    Dexcom Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 20, 2016
    Initiation Date
    February 23, 2016
    Classification Date
    April 11, 2016
    Termination Date
    August 11, 2017
    Address
    6340 Sequence Dr, N/A, San Diego, CA, 92121-4356, United States

    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

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

    Code Info

    Receiver Kit Number: STK-PU-001 Lot Number: 5176532 5176533 5176534 5176535 5176536 5188586 5189596 5190560 5191152 5191737 5191738 5192934 5193038 5194193 5194322 5195147 5195148 5195352 5195803 5195913 5196152 5197013 5197677 5198614 5200903 5200904 5200916 5201455 5201669 5202100 5202149 5202429 5202646 5202790 5202795 5202803 5202804 5202906 5203313 5203474 5203485 5203536 5204330 5204333 5205041 5206612 5206643 5208018 5208332 5208810 5210472

    Distribution

    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.

    Quantity

    5,722