{
  "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": "2026-09-03",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "221164",
      "product_res_number": "Z-2936-2026",
      "event_date_initiated": "2026-06-24",
      "event_date_posted": "2026-08-12",
      "recall_status": "Open, Classified",
      "res_event_number": "99261",
      "product_code": "QOF",
      "product_description": "BIOFIRE Respiratory Panel 2.1 (RP2.1) REF 423742\nUDI code: 00815381020529\n\nPCR-based multiplexed nucleic acid test, in vitro diagnostic",
      "code_info": "Part Number: 423742\nUDI-DI code: 00815381020529\nPouch Lot: 3VLB25\nKit Lot: 1872125",
      "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\n800-682-2666 Ext. 360",
      "reason_for_recall": "Due to increase in false negative results",
      "root_cause_description": "Under Investigation by firm",
      "action": "On 06/24/2026, an \"URGENT MEDICAL DEVICE CORRECTION\" Letter was emailed to customers informing them that bioMrieux received complaints of false-negative results associated with BIOFIRE RP2.1 kit lot 1872125 / pouch lot 3VLB25. An internal investigation confirmed the presence of incorrect PCR1 primers in a subset of pouches within BIOFIRE RP2.1 kit lot 1872125 introduced during reagent manufacturing. This field safety notice was issued because the incorrect PCR1 primers will lead to pouch pathogen assay negative results with passing control assays.\n\nCustomers are instructed to:\n\"Examine your inventory for the lot identified in this field safety notice.\n\"Cease use and discard any remaining product from this lot in your possession.\n\"Confirm the quantity of kits that have been destroyed, previously used, or returned on the attached Acknowledgement of Receipt Form.\n\"If you have further distributed this product, please identify any recipients and notify them at once.\n\"Complete the accompanying Acknowledgement of Receipt Form and return to bioMrieux so that bioMrieux may acknowledge your receipt of this notification.\n\"bioMerieux will be providing pouch credit for affected products.\n\nFor Questions - contact local Customer Service Representative at (800) 682-2666. For non-urgent inquiries, contact the Technical Support Center by email at biofiresupport@biomerieux.com.",
      "product_quantity": "2,370 pouches (79 kits)",
      "distribution_pattern": "U.S. Nationwide distribution in the states of AL, AR, IA, IL, KS, LA, MN, MO, TX, and WI.",
      "openfda": {
        "k_number": [
          "K242353",
          "K243544",
          "K231758",
          "K222736",
          "K230719",
          "K242071",
          "K243455",
          "K223591",
          "K252387",
          "K251978",
          "K233100",
          "K250995",
          "K251742",
          "K252269",
          "K213954",
          "K241194",
          "K252932",
          "K241806",
          "K241652",
          "DEN200031",
          "K242526",
          "K241240",
          "K232954",
          "K230956",
          "K250996",
          "K242465",
          "K220963",
          "K231481",
          "K233410",
          "K243400",
          "K250080",
          "K241573",
          "K243406"
        ],
        "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",
        "registration_number": [
          "3004141078",
          "2024800",
          "3009976420",
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        ],
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        ]
      }
    }
  ]
}