{
  "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
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  },
  "results": [
    {
      "cfres_id": "158837",
      "product_res_number": "Z-0028-2018",
      "event_date_initiated": "2017-09-15",
      "event_date_created": "2017-10-18",
      "recall_status": "Terminated",
      "event_date_terminated": "2023-07-28",
      "res_event_number": "78177",
      "product_code": "N/A",
      "product_description": "Xpert EV Assay, Catalog GXEV-100N-10.\n\nThe Cepheid Xpert EV assay is a reverse transcription polymerase chain reaction (RT-PCR) using the GeneXpert Dx System for the presumptive qualitative detection of enterovirus (EV) RNA in cerebrospinal fluid (CSF) specimens from individuals with signs and symptoms of meningitis.",
      "code_info": "batch 1000045409 (lot 06802)",
      "firm_fei_number": "3004530258",
      "recalling_firm": "Cepheid",
      "address_1": "904 E Caribbean Dr",
      "city": "Sunnyvale",
      "state": "CA",
      "postal_code": "94089-1189",
      "reason_for_recall": "Customers have reported a higher than expected number of invalid test results when using the recalled product per the package insert.",
      "root_cause_description": "Nonconforming Material/Component",
      "action": "Recall notification letters were sent out to affected consignees on 9/15/17.",
      "product_quantity": "977 kits (9770 units)",
      "distribution_pattern": "USA, Austria, Australia, Belgium, Brazil, Canada, Chile, Colombia, Germany, Spain, France, UK, Ireland, Israel, Italy, South Korea, Lebanon, Netherlands, Philippines, Saudi Arabia, Sweden, Uruguay",
      "openfda": {}
    }
  ]
}