{
  "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": "2026-08-20",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "204666",
      "product_res_number": "Z-0704-2024",
      "event_date_initiated": "2023-11-27",
      "event_date_posted": "2024-01-10",
      "recall_status": "Open, Classified",
      "res_event_number": "93526",
      "product_code": "QOF",
      "product_description": "The BIOFIRE Respiratory Panel 2.1 (RP2.1) is a PCR-based multiplexed nucleic acid test intended for use with the BIOFIRE FILMARRAY 2.0 or BIOFIRE FILMARRAY Torch Systems.",
      "code_info": "UDI-DI: 00815381020529.  Kit Lot/Pouch Lot/Expiration: 1667923/2X2423/June 26, 2024; 1890223/2YHT23/July 26, 2024",
      "firm_fei_number": "3002773840",
      "recalling_firm": "BioFire Diagnostics, LLC",
      "address_1": "515 S Colorow Dr",
      "city": "Salt Lake City",
      "state": "UT",
      "postal_code": "84108-1248",
      "additional_info_contact": "Customer Support Department\n800-736-6354 Ext. 5",
      "reason_for_recall": "A manufacturing event may contribute to elevated rates of false negative results while using gastrointestinal panel and respiratory panel, which could lead to inappropriate antibiotic treatment, no treatment, delay of treatment, and may provide false assurance to someone with a true infection, delayed identification of an outbreak, and may result in additional transmission.",
      "root_cause_description": "Process control",
      "action": "On 11/27/23, recall notices were emailed to laboratory directors who were asked to do the following:\n\nDiscontinue use and discard any remaining pouches that are subject to this recall.\n\nDistribute this information to all appropriate personnel in your laboratory, retain a copy in your files, and forward this information to all parties that may use this product, including others to whom you may have transferred our product.\n\nComplete and return the acknowledgement form using the following URL: https://www.biofiredx.com/recall5797\n\nCustomers with questions can contact Technical Support at biofiresupport@biomerieux.com or via telephone by dialing 1.800.735.6544 and selecting option 5.",
      "product_quantity": "57 Kits",
      "distribution_pattern": "US: NC, MO, NE, CT, IL, TN, NJ, OH, MA, CA, FL, UT, IA, KS, TX, MD",
      "openfda": {
        "k_number": [
          "K243406",
          "DEN200031",
          "K251742",
          "K252387",
          "K250080",
          "K222736",
          "K230956",
          "K241573",
          "K252269",
          "K251978",
          "K223591",
          "K231481",
          "K241194",
          "K242353",
          "K232954",
          "K242526",
          "K230719",
          "K233410",
          "K213954",
          "K220963",
          "K250996",
          "K242465",
          "K252932",
          "K241806",
          "K242071",
          "K243455",
          "K231758",
          "K243544",
          "K241240",
          "K241652",
          "K243400",
          "K250995",
          "K233100"
        ],
        "registration_number": [
          "",
          "3002773840",
          "3005248192",
          "2024800",
          "3014553740",
          "3004013603",
          "3011240982",
          "3010770794",
          "3006247421",
          "2023365",
          "3004141078",
          "3002777243",
          "3008632402",
          "3006028115",
          "3044563551",
          "3009613136",
          "3011057574",
          "3014654360",
          "3044741637",
          "1119779",
          "2243471",
          "3011104381",
          "3016838963",
          "3035381641",
          "3009976420",
          "1528450",
          "3007420875",
          "3004530258",
          "3014515702",
          "3003795116",
          "3019837962",
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        ],
        "fei_number": [
          "",
          "3002773840",
          "3005248192",
          "2024800",
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          "2243471",
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          "3035381641",
          "3009976420",
          "3007420875",
          "3004530258",
          "3014515702",
          "3003795116",
          "3019837962",
          "3021140368"
        ],
        "device_name": "Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents",
        "medical_specialty_description": "Microbiology",
        "regulation_number": "866.3981",
        "device_class": "2"
      }
    }
  ]
}