{
  "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": "194016",
      "product_res_number": "Z-1251-2022",
      "event_date_initiated": "2022-05-13",
      "event_date_created": "2022-06-08",
      "recall_status": "Open, Classified",
      "res_event_number": "90275",
      "product_code": "QLT",
      "product_description": "NeuMoDx Flu A-B/RSV/SARS-CoV-2 Vantage Test Strip, Model No. 300900",
      "code_info": "UDI-DI (GTIN): 10814278020830\n\nCartridge lot numbers 111915 - 117508",
      "firm_fei_number": "3010729479",
      "recalling_firm": "NeuMoDx Molecular Inc",
      "address_1": "1250 Eisenhower Pl",
      "city": "Ann Arbor",
      "state": "MI",
      "postal_code": "48108-3281",
      "additional_info_contact": "QIAGEN Technical Services\n800-362-7737",
      "reason_for_recall": "There is a potential for reduced analytical sensitivity for samples in the 1x - 3x LOD range for Flu A, RSV, and SARS-CoV-2 targets. This may lead to false negative results, allowing ongoing transmission to others and delaying appropriate treatment.",
      "root_cause_description": "Process control",
      "action": "On May 13, 2022, the firm distributed Urgent Medical Device Correction letters to impacted customers. The letter informed customers of the reduced analytical sensitivity for Flu A, SARS-CoV-2, and RSV. The firm also specified that only the RSV target showed a similar reduction in clinical sensitivity; Influenza A and SARS-CoV-2 did not show a reduction in clinical sensitivity. Influenza B is not affected by this issue.\n\nThe letter reminded users that negative results do not preclude infection with Influenza virus, RSV, and/or SARS-CoV-2, and the device should not be used as the sole basis for patient management and treatment decisions. Customers should share the notice with all affected users.\n\nIf you have any questions regarding this recall, please contact QIAGEN Technical Services at 1-800-362-7737 or techservice-na@qiagen.com.",
      "product_quantity": "459 kits US; 1626 kits OUS",
      "distribution_pattern": "Domestic distribution to FL, NY, MD, PA, VA,\nMI, TN, NM. Foreign distribution to AT, AU, BE, CH, DE,\nFI, FR, GB, GR, HK,\nID, IT, LT, NL, SA, SE, and\nSI.",
      "openfda": {
        "registration_number": [
          "3004141078",
          "3038610665",
          "3014214006",
          "3013019728",
          "2024800",
          "2243471",
          "2024674",
          "3017638293",
          "1528450"
        ],
        "fei_number": [
          "3004141078",
          "3038610665",
          "3014214006",
          "3013019728",
          "2024800",
          "2243471",
          "2024674",
          "1000122536",
          "3017638293"
        ],
        "device_name": "Covid-19 Multi-Analyte Respiratory Panel Nucleic Acid Devices",
        "medical_specialty_description": "Unknown",
        "regulation_number": "",
        "device_class": "N"
      }
    }
  ]
}