{
  "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": "Houston",
      "state": "TX",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "87541",
      "recalling_firm": "AZURE BIOTECH INC",
      "address_1": "5250 Gulfton St Ste 2c",
      "address_2": "N/A",
      "postal_code": "77081-2936",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit",
      "distribution_pattern": "Worldwide distribution - U.S. Nationwide distribution in the states of CA. FL, GA, IL, LA, MD, MN, NC, TX, UT, VA and WA. The country of Canada.",
      "recall_number": "Z-1432-2021",
      "product_description": "Assure COVID-19 IgG/IgM Rapid Test Device  that include:  1) Pouch Label - FaStep Rapid Diagnostic Test *** Rapid  Reliable  Simple *** COVID-19 IgG/IgM Rapid Test Device (Whole blood/Serum/Plasma) *** For Emergency Use Authorization Only,  Box Label - FaStep Rapid Diagnostic Test *** COVID-19 IgG/IgM Rapid Test Device (Whole blood/Serum/Plasma) *** For Emergency Use Authorization Only *** For in vitro diagnostic use only,  and     2) Pouch Label - ECOTEST RAPID DIAGNOSTIC TEST *** /Rapid / Reliable / Simple/ *** COVID-19 IgG/IgM Rapid Test Device (Whole blood/Serum/Plasma) *** For Emergency Use Authorization Only,  Box Label - ECOTEST RAPID DIAGNOSTIC TEST *** Rapid  Reliable  Simple *** COVID-19 IgG/IgM Rapid Test Device *** For Professional in vitro diagnostic use only *** For Emergency Use Authorization Only.",
      "product_quantity": "Total 100,000 kits (FaStep and EcoTest Rapid Diagnostic Test kits)",
      "reason_for_recall": "Due to Products being incorrect labeling \"for diagnostic use\" and labelled with an unsupported 24 month expiration dating.",
      "recall_initiation_date": "20210302",
      "center_classification_date": "20210416",
      "termination_date": "20230331",
      "report_date": "20210428",
      "code_info": "Lot Numbers:  I2004001, I2004003, I2006128, I2005023, and I2006030",
      "more_code_info": ""
    }
  ]
}