{
  "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": "2026-07-08",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Malvern",
      "state": "PA",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "98232",
      "recalling_firm": "Fujirebio Diagnostics, Inc.",
      "address_1": "201 Great Valley Pkwy",
      "address_2": "N/A",
      "postal_code": "19355-1308",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "US Nationwide distribution in the states of Arizona, California, Florida, Indiana, Kansas, Kentucky, Maryland, Massachusetts, Minnesota, New Jersey, Pennsylvania, Texas, Washington.",
      "recall_number": "Z-1305-2026",
      "product_description": "Product Name: Lumipulse G ¿-Amyloid 1-42-N Plasma Immunoreaction Cartridges  Model/Catalog Number: 235447  Software Version: Not Applicable  Product Description: Lumipulse G ¿-Amyloid 1-42-N Plasma Immunoreaction Cartridges (IRC):  Lumipulse G ¿-Amyloid 1-42-N Plasma is an assay system, including  a set of immunoassay reagents (Lumipulse G ¿-Amyloid 1-42-N Plasma IRC), for the quantitative measurement of ¿-Amyloid 1-42 in K2EDTA plasma specimens based on chemiluminescent enzyme immunoassay (CLEIA) technology13 by a specific two-step immunoassay method on the LUMIPULSE G System.    Lumipulse G ¿-Amyloid 1-42-N Plasma Immunoreaction Cartridges (IRC):  3 ¿ 14 Tests: 3 racks, 14 IRCs per rack, 1 test per IRC.  Each IRC contains (abbreviated contents):   1. Antibody-Coated Particle Solution: (Contains anti-¿-amyloid 1-42 monoclonal antibody (mouse)-coated particles). This solution contains gelatin and turns into gel at 15¿C or lower,   2. Enzyme-Labeled Antibody Solution: (Contains alkaline phosphatase (ALP)-labeled anti-¿-amyloid 1-42 monoclonal antibodies (mouse) conjugate),   3. Assay Specific Solution: (Contains detergents in 50 mM MES buffer)  Component: Yes. Lumipulse G pTau217/B-Amyloid 1-42 Plasma Ratio",
      "product_quantity": "1423 units",
      "reason_for_recall": "Customers may experience inaccurate test results by observing a higher frequency of classification in the indeterminate and positive zone and/or low specificity when compared back to FDA-cleared CSF ratio/PET imaging, due to falsely elevated positive ratio or falsely elevated indeterminate ratio results causing an incorrect classification of a patient as having amyloid pathology associated with Alzheimer s disease (positive result) and/or requiring more clinical testing of that patient (indeterminate result).",
      "recall_initiation_date": "20251211",
      "center_classification_date": "20260205",
      "report_date": "20260211",
      "code_info": "Model/Catalog Number: 235447; UDI-DI: 04987270235447; Lot Numbers: C5C6022U, C5C6045U;"
    }
  ]
}