{
  "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": "2026-09-10",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "191800",
      "product_res_number": "Z-0947-2022",
      "event_date_initiated": "2022-01-24",
      "event_date_created": "2022-04-15",
      "recall_status": "Open, Classified",
      "res_event_number": "89511",
      "product_code": "QLW",
      "product_description": "Matrix Clinical Solution At-Home COVID-19 Test",
      "code_info": "Product Number SKU: 15206\nAll Test Kits\nNo Lot Numbers",
      "firm_fei_number": "3021556946",
      "recalling_firm": "Matrix Medical Network",
      "address_1": "9201 E Mountain View Rd",
      "city": "Scottsdale",
      "state": "AZ",
      "postal_code": "85258-5199",
      "additional_info_contact": "Laura Vivian\n855-362-5221",
      "reason_for_recall": "Due to COVID-19 Test not being authorized for home sample collection.",
      "root_cause_description": "Other",
      "action": "On 01/24/2022 and 03/16/2022, the firm contacted its customers via telephone to informing them that the recall, removal of unused test kits, is being initiated because it appears that sample collection was being conduct from a home setting.  FDA has not authorized this test for at-home sample collection.\n\nOn 03/18/2022, the firm sent an \"URGENT MEDICAL DEVICE RECALL\" Letter via US Postal to customer.\n\nCustomers are being instructed to:\n1. Immediately discard the product.\n2. If product was used, it is recommended that the user of the product talk to their health care provider if there is any concern about their test results.\n3. If the product was further distributed to another person, please notify them of this recall and share the recall letter with them\n4. Complete and return the enclosed response form to the below address as soon as possible:\n- If returning it by email: labsupport@matrixhealth.net\n- If returning it by mail: Matrix Clinical Labs, 8161 Maple Lawn Blvd., Ste. 375 Fulton, MD 20759\n\nFor questions, call us at 1-855-362-5221. We are available Monday-Friday 8am-4pm EST.",
      "product_quantity": "3,226 kits",
      "distribution_pattern": "U.S.: AL, AZ, CA, CO, CT, DC, DE, FL, GA, LA, MA, MD, MI, MN, NH, NJ, NY, OH, OK, PA, TN, TX, UT, VA, and WV.\n\nO.U.S.: N/A",
      "openfda": {
        "registration_number": [
          "1930987",
          "3013160357",
          "3005174594",
          "2321034"
        ],
        "fei_number": [
          "1930987",
          "3003399884",
          "3013160357",
          "3005174594"
        ],
        "device_name": "Covid-19 Test Home Collection Kit Devices",
        "medical_specialty_description": "Unknown",
        "regulation_number": "",
        "device_class": "N"
      }
    }
  ]
}