{
  "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": "204168",
      "product_res_number": "Z-0451-2024",
      "event_date_initiated": "2023-10-17",
      "event_date_posted": "2023-12-01",
      "recall_status": "Open, Classified",
      "res_event_number": "93360",
      "product_code": "PEN",
      "k_numbers": [
        "K193519"
      ],
      "product_description": "BIOFIRE Blood Culture Identification 2 (BCID2) Panel, REF: RFIT-ASY-0147, used with Maine Molecular Quality Controls, Inc (MMQCI) FilmArray BCID2 Control Panel M416, which is referenced in Quality Control Materials for use with BIOFIRE FILMARRAY and BIOFIRE SPOTFIRE Panels - FLM1-PRT-0251",
      "code_info": "REF/UDI-DI: RFIT-ASY-0147/00815381020338. \nFLM1-PRT-0251-16 and prior.",
      "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. 360",
      "reason_for_recall": "Routine quality control testing of affected blood culture identification panel with affected control panel may need to be amended, due to control panel/instrument characteristic changes, that lead C. tropicalis to be amplified in some portion of test runs, but then it's reported as \"Not Detected\" because the assay amplicon Tm is outside the acceptable limit assigned for calling positive results.",
      "root_cause_description": "Process control",
      "action": "On 10/17/23, \"URGENT: MEDICAL DEVICE CORRECTION\" notices were mailed to customers who were asked to do the following:\n\n1) Review a complete list of BIOFIRE Quality Control Materials and references, for Example IQCP Risk Analysis can be found in BIOFIRE QC Tech Note (FLM1-PRT-0251), available from bioMrieux customer support.\n\n2) Assess your Individualized Quality Control Plan (IQCP) and prepare for supplemental C. tropicalis testing if a Candida tropicalis Not Detected result is reported when testing with the MMQCI FilmArray BCID2 Control Panel M416 and/or amend testing plans to include alternate Quality Control materials such as those in FLM1-PRT-0251.\n\n3) Complete and return the via email to recall5788@biomerieux.com\n\nContact customer support at biofiresupport@biomerieux.com or via telephone by dialing 1.800.735.6544 and selecting option 5 for Product Technical Support with any questions or concerns.",
      "product_quantity": "32,910",
      "distribution_pattern": "Worldwide Distribution: US (nationwide): DE, OH, NY, IL, KY, FL, GA, KS, CA, WI, NC,, AK, PA, MN, ND, IN, AR, CO, UT, TX, AL, NJ, MD, SD, LA, OR, MA, ID, NE, MT, VA, IA, MO, WV, TN, MI, WY, SC, AZ, WA, NH, OK, HI, MS, DC, VT, CT, NM, RI, ME, NV; and \n\nOUS (foreign) to countries of: Algeria, Angola, Armenia, Bahrain, Bolivia, Bosnia- Herzegovina, Brunei, Bulgaria, Costa Rica, Croatia, Cyprus, Dominican Republic,  Dutch Antilles, Ecuador, El Salvador, Estonia, Gabon, Georgia, Guam, Guatemala, Honduras, Indonesia, Ireland, Iceland, Israel, Ivory Coast, Jordan, Kosovo, Kuwait, Latvia, Lebanon, Lithuania, Macao, Macedonia, Malaysia, Mali, Mongolia, Morocco, New Zealand, Nicaragua, Oman, Pakistan, Panama, Paraguay, Peru, Qatar, Romania, Saudi Arabia, Serbia , Slovenia, Tunisia, Uganda, United Arab Emirate, Uruguay, Venezuela, Vietnam, Zimbabwe, Argentina, Australia, Brazil, Canada, Chile, China, Colombia, Czech Republic, Spain, France, United Kingdom, Greece, India, Italia, Japan, Korea, Netherlands, Poland, Portugal, Sweden, Singapore, Thailand, Turkey, Taiwan, Switzerland, Austria, Denmark, Finland, Germany, Belgium, Hungary, South Africa, Philippines, Norway, Mexico",
      "openfda": {
        "k_number": [
          "K243013",
          "K193519",
          "K243759",
          "K130914",
          "K182619",
          "K160457",
          "K143171",
          "K190341",
          "K213236",
          "K181493",
          "K132843"
        ],
        "registration_number": [
          "3006028115",
          "3002773840",
          "3010749841",
          "3008632402"
        ],
        "fei_number": [
          "3006028115",
          "3002773840",
          "3010749841",
          "3008632402"
        ],
        "device_name": "Gram-Negative Bacteria And Associated Resistance Markers",
        "medical_specialty_description": "Microbiology",
        "regulation_number": "866.3365",
        "device_class": "2"
      }
    }
  ]
}