{
  "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": "2026-09-17",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "193158",
      "product_res_number": "Z-1009-2022",
      "event_date_initiated": "2022-04-06",
      "event_date_created": "2022-05-06",
      "recall_status": "Open, Classified",
      "res_event_number": "90013",
      "product_code": "QJR",
      "product_description": "Accula SARS-CoV-2 Test, REF: COV4100",
      "code_info": "UDI/DI: B540COV41000;\nP22006-026,\nP22010-021,\nP22024-023,\nP22024-030,\nP22026-006,\nP22026-012,\nP22026-016 ,\nP22010-001,\nP22010-030,\nP22024-026,\nP22024-032,\nP22026-007,\nP22026-013,\nP22026-017 ,\nP22010-017,\nP22010-032,\nP22024-027,\nP22026-002,\nP22026-008,\nP22026-014,\nP22026-019 ,\nP22010-019,\nP22024-021,\nP22024-028,\nP22026-004,\nP22026-009,\nP22026-015,\nP22032-011",
      "firm_fei_number": "3013026082",
      "recalling_firm": "MESA BIOTECH, INC",
      "address_1": "6190 Cornerstone Ct E Ste 220 6190 Cornerstone Ct E",
      "address_2": "Ste 220",
      "city": "San Diego",
      "state": "CA",
      "postal_code": "92121-4701",
      "additional_info_contact": "Ron O'Brien \n858-863-7972",
      "reason_for_recall": "SARS-CoV-2 Test has an increased potential for false positive results, which may lead to a delay in correct diagnosis and treatment.",
      "root_cause_description": "Material/Component Contamination",
      "action": "On 04/06/22, recall notices were mailed to customers.  Customers were informed that the reliability of negative test results is not affected.  Customers with affected devices were asked to do the following:\n1. Discontinue use of any affected product immediately\n2. All affected product must either be returned or discarded. Replacement product will be provided for all returned and discarded product upon receipt of Customer/Distributor Response Sheet.\n3. Notify all impacted users in your facility. If you have shipped any of these lots outside of your facility, you must notify those customers or facilities of this voluntary recall.\n4. Complete and return the Customer/Distributor Response Sheet, which can be emailed to USSD2.customercare@thermofisher.com\nCustomers with questions are encouraged to contact the recalling firm at: +1-858-800-4929, or 1-800-955-6288, option 2.",
      "product_quantity": "6162",
      "distribution_pattern": "US Nationwide distribution in the states of CA, TX, MA, NY, FL, NC, NJ, GA, CO, HI, PA, WA, NY, VA, MD, KY, WI, IL, PR, ND, MI, TN, AZ, UT.",
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        ],
        "device_name": "Reagents, 2019-Novel Coronavirus Nucleic Acid",
        "medical_specialty_description": "Unknown",
        "regulation_number": "",
        "device_class": "N"
      }
    }
  ]
}