{
  "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-1304-2026",
      "product_description": "Product Name: Lumipulse pTau 217 Plasma Controls  Model/Catalog Number: 81558  Software Version: Not Applicable  Product Description: Lumipulse pTau 217 Plasma Controls:  This quality control product can be used as an objective judgement of the laboratory s procedures and personnel techniques when analyzing pTau 217 in K2EDTA plasma on the LUMIPULSE G System. It is a valuable tool to assess good laboratory practices. Two levels of control are available to compare observations with expected ranges therefore assuring consistent performance of the testing system within the clinical range.    Lumipulse pTau 217 Plasma Controls: Liquid (Frozen),  2 ¿2 Concentrations  L1     Level 1 (2¿ 1.5 mL)  L2     Level 2 (2¿ 1.5 mL)  Contains Tris buffer with protein (bovine) and chemical stabilizers. Preservative:  0.1% ProClin 300, 0.05% ProClin 950  Component: Yes. Lumipulse G pTau217/B-Amyloid 1-42 Plasma Ratio",
      "product_quantity": "148 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: 81558; UDI-DI: 05414470815586; Lot Numbers: D6C6092U, D6C6092U1, D6C6123U;"
    }
  ]
}