{
  "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": "2026-09-05",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "218604",
      "product_res_number": "Z-1565-2026",
      "event_date_initiated": "2026-02-09",
      "event_date_posted": "2026-03-13",
      "recall_status": "Open, Classified",
      "res_event_number": "98400",
      "product_code": "OZE",
      "k_numbers": [
        "K171792"
      ],
      "product_description": "Product Name: ID NOW\" Influenza A & B 2\nModel/Catalog Number: 427-000\nSoftware Version: Not Applicable\nProduct Description: Influenza A/B virus nucleic acid IVD, kit, nucleic acid technique\nComponent: Not Applicable",
      "code_info": "List Number: 427-000;\nUDI-DI: 10811877010422;\nLot Number: 000X133126;\nExpiry: 2027 02 21;",
      "firm_fei_number": "1221359",
      "recalling_firm": "Abbott Diagnostics Scarborough, Inc.",
      "address_1": "10 Southgate Rd",
      "city": "Scarborough",
      "state": "ME",
      "postal_code": "04074-8303",
      "additional_info_contact": "Vicki Assardo\n+1-224-6681505",
      "reason_for_recall": "It was confirmed that the impacted lot has a higher occurrence of invalid rates when compared to the product Instructions for Use.",
      "root_cause_description": "Under Investigation by firm",
      "action": "On or about February 9, 2026 Product Removal Notice letters were sent to customers and distributors. Actions to be taken:\n\" Quarantine and discontinue use of any remaining inventory of the impacted lot.\n\" Count how many unused kit boxes (24 tests / 1 kit box) of remaining impacted inventory require replacement.\n\" Complete and return the Customer Acknowledgment Form (Form must be fully completed, signed and returned to receive replacement product).\n\" Complete the Customer Request for Replacement Product Form.\n\" Customer Service will arrange replacement product and return of your product. \n\" Retain this letter for your records.\nforward this notice to those you have further distributed or transferred product to.",
      "product_quantity": "111984 units",
      "distribution_pattern": "US Nationwide distribution.",
      "openfda": {
        "k_number": [
          "K132508",
          "K241110",
          "K190204",
          "K133869",
          "K181736",
          "K200370",
          "K230236",
          "K153148",
          "K182513",
          "K141859",
          "K131728",
          "K140857",
          "K220801",
          "K243931",
          "K113777",
          "K190302",
          "K243274",
          "K171641",
          "K161556",
          "K172091"
        ],
        "registration_number": [
          "1650733",
          "3007799234",
          "3019946577",
          "3012494290",
          "3008632402",
          "3004141078",
          "3023372670",
          "1528450",
          "1050190",
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          "3023999024",
          "3002773840",
          "3005360469",
          "3038610665",
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          "3029059580",
          "2243471",
          "9610126",
          "3006028115",
          "1221359",
          "3010770794",
          "3003795116"
        ],
        "fei_number": [
          "3002806559",
          "3007799234",
          "3005670738",
          "3019946577",
          "3012494290",
          "3008632402",
          "3004141078",
          "1000122536",
          "3023372670",
          "1050190",
          "3013019728",
          "3023999024",
          "3002773840",
          "3038610665",
          "3003018722",
          "3029059580",
          "2243471",
          "3006028115",
          "1221359",
          "3002524000",
          "3010770794",
          "3003795116"
        ],
        "device_name": "Influenza A And Influenza B Multiplex Nucleic Acid Assay",
        "medical_specialty_description": "Microbiology",
        "regulation_number": "866.3980",
        "device_class": "2"
      }
    }
  ]
}