{
  "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-1303-2026",
      "product_description": "Product Name: Lumipulse G pTau 217 Plasma Calibrators  Model/Catalog Number: 81557  Software Version: Not Applicable  Product Description: Lumipulse G pTau 217 Plasma Calibrators:  The pTau 217 plasma concentration of a specimen is automatically calculated from the calibration curve, which is also automatically calculated from calibration data. The result of the calculation is reported in  pg/mL.  Lumipulse G pTau 217 Plasma Calibrators: Liquid (Frozen),  1x1.5 mL (5 Concentrations)  CAL 1             0 pg/mL pTau 217 Plasma Calibrator  CAL 2     0.250 pg/mL pTau 217 Plasma Calibrator  CAL 3     1.000 pg/mL pTau 217 Plasma Calibrator  CAL 4     5.000 pg/mL pTau 217 Plasma Calibrator  CAL 5   10.000 pg/mL pTau 217 Plasma Calibrator  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": "117 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: 81557; UDI-DI: 05414470815579; Lot Numbers: D5C6094U, D5C6125U;"
    }
  ]
}