{
  "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": "2026-08-13",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "196683",
      "product_res_number": "Z-0345-2023",
      "event_date_initiated": "2022-10-17",
      "event_date_posted": "2022-12-06",
      "recall_status": "Open, Classified",
      "res_event_number": "91075",
      "product_code": "PRH",
      "k_numbers": [
        "K192665"
      ],
      "product_description": "Accelerate PhenoTest BC kit REF 10101018",
      "code_info": "Part Number: 10101018\nUDI-DI Code: 00862011000307\nLot Numbers:\n5549A\n5566A\n5588A\n5606A\n5612A",
      "firm_fei_number": "3010671651",
      "recalling_firm": "Accelerate Diagnostics Inc",
      "address_1": "3950 S Country Club Rd Ste 470 3950 S Country Club Rd",
      "address_2": "Ste 470",
      "city": "Tucson",
      "state": "AZ",
      "postal_code": "85714-2240",
      "additional_info_contact": "Kurtis Montegna\n520-260-6610",
      "reason_for_recall": "Due improperly formulated and released bulk lot of fluorescence in situ hybridization (FISH) probes resulting in false positive identification results for Staphylococcus aureus and Streptococcus spp.",
      "root_cause_description": "Mixed-up of materials/components",
      "action": "On 11/04/2022, the firm communicated an \"URGENT: MEDICAL DEVICE RECALL\" Letter to customers informing them that the firm has become aware of complaints concerning false positive identification results for Staphylococcus aureus and Streptococcus spp. when using the Accerlerate PhenoTest BC kits.\n\nCustomer are instructed to:\n(1) Share this customer notification with all who need to be made aware within their organization.\n(2) Appropriately destroy all affected Accelerate PhenoTest BC kits by defacing all labeling and disposing in accordance with site biohazard or waste policies and procedure.\n(3) Complete the Recall Response Form and return it to Accelerate Diagnostics.\n(4) Retrospectively review runs from affected lots, specifically those runs with positive identification results for either Staphylococcus aureus or Streptococcus spp. Follow their institutional policies and processes to review prior patient results related to the described issue.\n(5) Continue to report all technical issues through Accelerate Technical Support.\n\nContact for Questions:\nNA Customer Service & Technical Support\nToll free: +1 (888) 586 2939 opt. 4\nDirect: +1 (520) 365 3100\nEmail: support@axdx.com",
      "product_quantity": "200 kits",
      "distribution_pattern": "U.S.: AR, CA, DC, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MN, MO, MS, MT, NC, ND, NJ, NY, OH, PA, RI, SC, TN, TX, VA, WA, and WV.\n\nO.U.S.: Germany, Italy, Kuwait, Latvia, Poland, Portugal, Romania, Saudi Arabia, Spain, and United Arab Emirates",
      "openfda": {
        "k_number": [
          "K192665",
          "DEN160032"
        ],
        "device_name": "Positive Blood Culture Identification And Ast Kit",
        "medical_specialty_description": "Microbiology",
        "regulation_number": "866.1650",
        "device_class": "2"
      }
    }
  ]
}