{
  "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": "2026-03-18",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Waltham",
      "state": "MA",
      "country": "United States",
      "classification": "Class III",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "90998",
      "recalling_firm": "LumiraDx",
      "address_1": "221 Crescent St",
      "address_2": "N/A",
      "postal_code": "02453-3475",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "E-Mail",
      "distribution_pattern": "US Nationwide distribution.",
      "recall_number": "Z-0135-2023",
      "product_description": "LumiraDx SARS-CoV-2 Antigen (Ag) Liquid Quality Control Kit  Catalog #: L016080109002 (EUA)    The LumiraDx SARS-CoV-2 Quality Controls are intended for liquid quality  control testing performed on the LumiraDx Instrument when used with  the LumiraDx SARS-CoV-2 Ag Test Strip. The Quality Controls provide users  with assurance that the device is performing within specification",
      "product_quantity": "83 kits",
      "reason_for_recall": "Assigned vial lot numbers for the incorrect type of product. SARS-CoV-2 & Flu A/B lot numbers were incorrectly assigned to the positive and negative vial lot numbers for SARS-CoV-2 Ag LQCs within batch 2002204017, which should have been assigned SARS-CoV-2 Ag lot numbers resulting in an error message and preventing use of the LQC",
      "recall_initiation_date": "20220923",
      "center_classification_date": "20221026",
      "termination_date": "20241213",
      "report_date": "20221102",
      "code_info": "LQC Kit: 2002204017 Positive Control Vial: 1000 1710 0014 0141 Negative Control Vial: 1000 1720 0014 0142  Exp. Date: 01-Mar-2023",
      "more_code_info": ""
    }
  ]
}