{
  "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": "2026-08-15",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "65632",
      "product_res_number": "Z-0376-2008",
      "event_date_initiated": "2007-09-05",
      "event_date_posted": "2008-01-12",
      "recall_status": "Terminated",
      "event_date_terminated": "2008-04-04",
      "res_event_number": "45494",
      "product_code": "NJR",
      "k_numbers": [
        "K060540"
      ],
      "product_description": "Cepheid, Xpert GBS Assay Diagnostic Test Kit  Part No: GXGBS-100N-10 (in foil pouch) for use with the GeneXpert DX System, Cepheid, Sunnyvale, CA  94089",
      "code_info": "Lot Number : 1402",
      "firm_fei_number": "3004530258",
      "recalling_firm": "Cepheid",
      "address_1": "904 E Caribbean Dr",
      "city": "Sunnyvale",
      "state": "CA",
      "postal_code": "94089-1189",
      "additional_info_contact": "John Bishop, CEO\n408-541-4191",
      "reason_for_recall": "Labeling Error: Some cartridges may be mislabeled as \"Xpert EV\" instead of \"Xpert GBS\". (The information embedded in the barcode label on the cartridge is correct for Xpert GBS and brings up the GBS assay definition file)",
      "root_cause_description": "Release of Material/Component prior to receiving test results",
      "action": "Consignees were sent a Correction and Removal letter on 09/04/2007, notifying them that there was a labeling error with some of the cartridges labels indicating Xpert EV instead of Xpert GBS on the cartridge label.  They are asked to discontinue using it immediately and return to Cepheid.",
      "product_quantity": "105",
      "distribution_pattern": "Worldwide Distribution",
      "openfda": {
        "k_number": [
          "K182467",
          "K170557",
          "K143312",
          "K022504",
          "K060540",
          "K121044",
          "K090191",
          "K162772",
          "K062948",
          "K181156",
          "K203429",
          "K173725",
          "K222638",
          "K133503",
          "K121539",
          "K173250",
          "K111860",
          "K112125"
        ],
        "registration_number": [
          "1528450",
          "3004530258",
          "3006198300",
          "1524213",
          "2023365",
          "3007420875",
          "2024800",
          "3012918440",
          "3016838963",
          "1119779",
          "3009613136",
          "3016733849",
          "3026312356"
        ],
        "fei_number": [
          "3004530258",
          "3006198300",
          "1524213",
          "2023365",
          "3007420875",
          "2024800",
          "3012918440",
          "3016838963",
          "1119779",
          "3009613136",
          "3016733849",
          "1000122536",
          "3026312356"
        ],
        "device_name": "Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test",
        "medical_specialty_description": "Microbiology",
        "regulation_number": "866.3740",
        "device_class": "1"
      }
    }
  ]
}