{
  "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": "2026-10-19",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 3
    }
  },
  "results": [
    {
      "cfres_id": "221921",
      "product_res_number": "Z-0148-2027",
      "event_date_initiated": "2026-08-12",
      "event_date_posted": "2026-10-13",
      "recall_status": "Open, Classified",
      "res_event_number": "99592",
      "product_code": "QDP",
      "k_numbers": [
        "K243222"
      ],
      "product_description": "Generic Name: FilmArray Pneumonia Panel\nGeneric Name: FilmArray Pneumonia Panel\nModel/Catalog Number: RFIT-ASY-0144 (30 pack), RFIT-ASY-0145 (6 pack), FLM1-ASY-0150 (Verification Kits). Verification kit lots (FLM1-ASY-0150) are a sales configuration that consume kits from panel lots (RFIT-ASY-0144).\nSoftware Version: N/A\nProduct Description: Multiple-type respiratory pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)\nComponent: N/A",
      "code_info": "Lot Code: UDI nos 00815381020178 (30 pack), 00815381020185 (6 pack); Model Nos RFIT-PRT-0144 (30 pack), RFIT-ASY-0145 (6 pack), FLM1-ASY-0150 (Verification Kit); Lot Numbers 0638726, 0676626, 0676726, 0716526, 0727826, 0767926, 0804526, 0804626, 0860926, 0882826, 0882926, 0883026, 0914626, 0914726, 0914826, 0914926, 0969126, 0969726, 0978026, 0978126, 0978226, 0978326, 0997626, 0997826, VK0997826, 0999226, 1020826, 1020926, 1105426, 1119126, 1119226, 1119326, 1119426, 1151826, 1152326, 1152426, 1179726, 1219026, 1267526, 1286226, 1286326, 1286426, 1346126, 1402726, 1402826, 1402926, 1419126, 1419226, 1437526, 1478926, 1560326, 1560426, 1560526, 1630726, 1656826, 1683726, 1702326, 1708826",
      "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\n+1-800-6822666 Ext. 360",
      "reason_for_recall": "Due to potential contaiminated of spefic lots of pneumonia and joint infection panels that could result in false positive results",
      "root_cause_description": "Under Investigation by firm",
      "action": "On 09/03/2026, an \"URGENT: MEDICAL DEVICE RECALL (CORRECTION)\" Letter was emailed to customers informing them that, bioMrieux internally identified increased rates of KPC unexpected positives in Quality Control (QC) testing of the BIOFIRE FILMARRAY PN Panel, BIOFIRE FILMARRAY PNplus Panel, and BIOFIRE JI Panel. Internal testing reproduced KPC unexpected positive results, suggesting KPC nucleic acid contamination in reagent manufacturing at levels that can lead to false positive results.\n\nCustomers are instructed to:\n\" Examine inventory for the lots identified in this recall.\n\" If a positive KPC result obtained when using the affected product is inconsistent with local resistance epidemiology and clinical data, then the result should be confirmed with an alternative method.\n\" If customer has further distributed or transferred this product to another facility, identify any recipients, notify them at once, and forward this notice.\n\" Post the recall (correction) letter on or near affected products as a constant reminder of the actions that need to be taken.\n\" Complete the accompanying Acknowledgement of Receipt Form and return to bioMrieux so that bioMrieux may acknowledge your receipt of this notification.\n\nFor questions - contact your local Customer Service Representative at 1-800-682-2666, selecting option 1 for Technical Support and option 3 for BIOFIRE, or email biofiresupport@biomerieux.com",
      "product_quantity": "4,892",
      "distribution_pattern": "Worldwide - U.S. Nationwide distribution including in the states and territory of AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, GU, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, PR, SC, SD, TN, TX, UT, VA, WA, WI, WV, and WY. The countries of United Arab Emirates, Netherland Antilles, Argentina, Austria, Bosnia and Herzegovina, Belgium, Bulgaria, Bolivia, Canada, Switzerland, Chile, China, Colombia, Costa Rica, Czech Republic, Germany, Denmark, Dominican Republic, Algeria, Ecuador, Spain, Finland, France, United Kingdom, Greece, Guatemala, Hong Kong, Honduras, Croatia, Hungary, Indonesia, Israel, India, Italy, Japan, Korea, Lebanon, Sri Lanka, Lithuania, Mexico, Malaysia, Nicaragua, Panama, Peru, Philippines, Poland, Portugal, Paraguay, Romania, Serbia, Singapore, El Salvador, Thailand, Taiwan, Venezuela, Vietnam.",
      "openfda": {
        "k_number": [
          "K212727",
          "K180966"
        ],
        "device_name": "Respiratory Panel",
        "medical_specialty_description": "Microbiology",
        "regulation_number": "866.3985",
        "device_class": "2",
        "registration_number": [
          "3002773840"
        ],
        "fei_number": [
          "3002773840"
        ]
      }
    }
  ]
}