{
  "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": "2026-04-01",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Waltham",
      "state": "MA",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "87259",
      "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": "Worldwide distribution.  US states of CA, GA, PA, SD. (Updated 3/15/2021) Austria, Germany, Ireland, Italy, Lebanon, Netherlands, Slovenia, Spain, United Kingdom.",
      "recall_number": "Z-1132-2021",
      "product_description": "LumiraDx SARS-CoV-2 Ag Test Strip Kit US EUA (48 Tests / EN).  LumiraDx Severe Acute Respiratory Syndrome (SARS) CoV-2 Antigen (Ag) Test Strips, Catalog #:L016000109048.    Part of the LumiraDx Platform, a point of care system for professional use for in vitro diagnostic tests. It comprises a portable LumiraDx Instrument and a LumiraDx Test Strip for the required test.",
      "product_quantity": "3,274,272 strips (Updated 3/15/2021 added 69,168 strips)",
      "reason_for_recall": "Observations of potential false positive results in the specified lots. Use of these test strips may result in false positive patient test results and potential exposure to unnecessary treatment or quarantine.",
      "recall_initiation_date": "20210111",
      "center_classification_date": "20210217",
      "termination_date": "20211203",
      "report_date": "20210224",
      "code_info": "Catalog #:L016000109048  Lot #: 5000269 (GM2000238), 5000280 (GM2000232), 5000306 (GM2000261)  (Updated 3/15/2021) 5000323 (GM2000354), 6000142 (GM2000296), 6000100 (GM2000322)"
    }
  ]
}