{
  "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": "192684",
      "product_res_number": "Z-0877-2022",
      "event_date_initiated": "2022-03-18",
      "event_date_posted": "2022-04-06",
      "recall_status": "Open, Classified",
      "res_event_number": "89855",
      "product_code": "NJR",
      "k_numbers": [
        "K181156"
      ],
      "product_description": "Panther Fusion GBS Assay Cartridges 96 Tests, Catalog Number: PRD-04484.  in vitro diagnostic test for group b streptococcus.",
      "code_info": "UDI: 15420045510890, Lot numbers: 274954, 284599, 296991, 300796, 309230, 309353",
      "firm_fei_number": "2024800",
      "recalling_firm": "Hologic, Inc",
      "address_1": "10210 Genetic Center Dr",
      "city": "San Diego",
      "state": "CA",
      "postal_code": "92121-4362",
      "additional_info_contact": "858-410-8000",
      "reason_for_recall": "Samples, run on a GBS Assay, that have analyte concentrations that are at or near the limit of detection may produce false negative results.",
      "root_cause_description": "Component change control",
      "action": "On 03/18/22, recall notices were sent to customers who were informed that the recalling firm is discontinuing the further sale of the affected GBS Assay for the foreseeable future.\n\nCustomers were asked to do the following:\n1) Discontinue use and destroy affected GBS assay kit lots and respective components.\n2) Complete and return the customer response form.\n\nCustomers with additional questions were encouraged to contact Technical Support at +1 888 484 4747 or +1 858 410 8511 between 5am PDT and 5 pm PDT, or by email at molecularsupport@hologic.com",
      "product_quantity": "2061",
      "distribution_pattern": "US: TX, TN, NY, NV, IN, AR, CA, CT, IL, NH, PA, WA, FL, OR, WV, VA, UT, MA, NJ, MI, PR\n\nOUS: CA",
      "openfda": {
        "k_number": [
          "K022504",
          "K222638",
          "K173250",
          "K111860",
          "K121044",
          "K062948",
          "K112125",
          "K143312",
          "K133503",
          "K203429",
          "K170557",
          "K060540",
          "K121539",
          "K090191",
          "K181156",
          "K162772",
          "K182467",
          "K173725"
        ],
        "device_name": "Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test",
        "medical_specialty_description": "Microbiology",
        "regulation_number": "866.3740",
        "device_class": "1",
        "registration_number": [
          "1528450",
          "3026312356",
          "3016733849",
          "1524213",
          "3007420875",
          "1119779",
          "3004530258",
          "2024800",
          "3009613136",
          "3012918440",
          "3016838963",
          "2023365",
          "3006198300"
        ],
        "fei_number": [
          "3026312356",
          "3016733849",
          "1524213",
          "3007420875",
          "1119779",
          "3004530258",
          "2024800",
          "3009613136",
          "3012918440",
          "3016838963",
          "1000122536",
          "2023365",
          "3006198300"
        ]
      }
    }
  ]
}