{
  "meta": {
    "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.",
    "terms": "https://open.fda.gov/terms/",
    "license": "https://open.fda.gov/license/",
    "last_updated": "2026-08-22",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "204243",
      "product_res_number": "Z-0734-2024",
      "event_date_initiated": "2023-02-09",
      "event_date_posted": "2024-01-16",
      "recall_status": "Completed",
      "res_event_number": "93393",
      "product_code": "QLG",
      "k_numbers": [
        "K213996"
      ],
      "product_description": "FreeStyle Libre 3 App, part of Continuous Glucose Monitoring System, when used on the Android 13 Operating System",
      "code_info": "UDI-DI: 00357599816001, Software v.3.4.0 and below",
      "firm_fei_number": "3002803444",
      "recalling_firm": "Abbott Diabetes Care, Inc.",
      "address_1": "1360 S Loop Rd",
      "city": "Alameda",
      "state": "CA",
      "postal_code": "94502-7000",
      "additional_info_contact": "Lindsy Delco\n510-749-5000",
      "reason_for_recall": "If using affected glucose monitoring app on Android 13 Operating System, extended periods of signal loss may be experienced, due to app not connected, which could impact ability to receive glucose reading/alarms, which could lead to undetected low or high glucose, which could result in delayed treatment: not taking insulin (for high glucose), or not taking glucose (for low glucose) when required.",
      "root_cause_description": "Software design",
      "action": "On 2/9/23, an Important Message/Communication was sent to customers informing them of the following:\n\nIf you experience extended periods of signal loss, either of the following actions should allow reconnection: 1) Turn your smartphone's Bluetooth OFF and then ON\n2) Turn your smartphone OFF and then ON\n\nTo be notified if extended periods of signal loss occur: 1) Open your FreeStyle Libre 3 app, navigate to Alarms, and configure your signal loss alarm to be ON with \"Override Do Not Disturb\" enabled. 2) Please refer to www.FreeStyleAndroid.com for more information on how to configure alarms.\n\nOn 2/27/23, another Important Message/Communication was sent to customers informing them that updated software version 3.4.2 was available to fix the connection issue.\n\nQuestions can be directed to Customer Care team at 1-855-632-8658. The team is available 7 days a week from 8 AM to 8 PM Eastern Time, excluding holidays.",
      "product_quantity": "45,173",
      "distribution_pattern": "US Nationwide distribution in the states of NY, CA, NJ, UT, PA, MS, OH, TX, MN, FL, LA, NE, MI, VA, NC, MA, IN, SC, IA.",
      "openfda": {
        "k_number": [
          "K193371",
          "K210943",
          "K212132",
          "K211102",
          "K202145",
          "K223537",
          "K213996",
          "K222280",
          "K201761"
        ],
        "registration_number": [
          "3016525500",
          "3007421145",
          "3033394445",
          "3003600763",
          "3006537560",
          "1450743",
          "3011536730",
          "3002807314",
          "2954323",
          "3006371704",
          "3004139819",
          "3008606429",
          "3009171251",
          "9710492",
          "3010893867"
        ],
        "fei_number": [
          "3003500908",
          "3016525500",
          "3003600763",
          "3033394445",
          "3002803444",
          "3006537560",
          "1450743",
          "3011536730",
          "3002807314",
          "3006371704",
          "3004139819",
          "3004173703",
          "3008606429",
          "3010893867",
          "3006759904"
        ],
        "device_name": "Integrated Continuous Glucose Monitoring System, Factory Calibrated, Not For Use With Automated Insulin Delivery Systems",
        "medical_specialty_description": "Clinical Chemistry",
        "regulation_number": "862.1355",
        "device_class": "2"
      }
    }
  ]
}