{
  "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": "2026-09-10",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 7
    }
  },
  "results": [
    {
      "cfres_id": "217940",
      "product_res_number": "Z-1301-2026",
      "event_date_initiated": "2025-12-11",
      "event_date_posted": "2026-02-05",
      "recall_status": "Open, Classified",
      "res_event_number": "98232",
      "product_code": "SET",
      "k_numbers": [
        "K242706"
      ],
      "product_description": "Product Name: Lumipulse G pTau217/B-Amyloid 1-42 Plasma Ratio\nModel/Catalog Number: CL0073\nSoftware Version: Not Applicable\nProduct Description: Lumipulse G pTau217/-Amyloid 1-42 Plasma Ratio is an in vitro diagnostic (IVD) test that combines the test results of the Lumipulse G pTau 217 Plasma assay and the Lumipulse G -Amyloid 1-42-N Plasma assay from the same patient specimen (K2EDTA plasma sample) into a numerical ratio. The Lumipulse G pTau 217/-Amyloid 1-42 Plasma Ratio Instructions For Use (IFU), CL0072, contains instructions on how to manually calculate the ratio and is supplied with each individual Lumipulse G assay.\n\nLumipulse G pTau217/-Amyloid 1-42 Plasma Ratio, Item# CL0073 \nis comprised of the following kits, which are imported:\nKit Description, Item#:\nImported from Fujirebio Europe (FRE):\nLumipulse G pTau 217 Plasma Immunoreaction Cartridges 81550\nLumipulse G pTau 217 Plasma Calibrators set 81557\nLumipulse pTau 217 Plasma Controls 81558\nLumipulse -Amyloid Plasma Controls 81559\n\nImported from Fujirebio Japan (FRI):\nLumipulse G -Amyloid 1-42-N Plasma Immunoreaction Cartridges 235447\nLumipulse G -Amyloid 1-42-N Plasma Calibrators set 235454\nComponent: No",
      "code_info": "Model/Catalog Number: CL0073;\nUDI-DI: 00869164000086;\nDistribution for Lumipulse G pTau217/B-Amyloid 1-42 Plasma Ratio (\"Ratio\") is related to the \"Ratio\" Instructions for Use (IFU). Therefore, each consignee has 1 \"Ratio\" in which they purchase the component kits for.",
      "firm_fei_number": "2521625",
      "recalling_firm": "Fujirebio Diagnostics, Inc.",
      "address_1": "201 Great Valley Pkwy",
      "city": "Malvern",
      "state": "PA",
      "postal_code": "19355-1308",
      "additional_info_contact": "Gregory Dickson\n1-610-2403888",
      "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).",
      "root_cause_description": "Under Investigation by firm",
      "action": "On or about December 11, 2025 URGENT PRODUCT CORRECTION NOTIFICATION letters were sent to customers. Actions to be taken:\n- Immediately discontinue using the associated Lots listed above for the Lumipulse G pTau217/-Amyloid 1-42 Plasma Ratio.\n- Review this letter with your Medical Director to determine the appropriate course of action, including for any previously generated results, if applicable.\n- Notify your ordering physician or health care provider as appropriate.\n- The test results must be interpreted in conjunction with other diagnostic tools and clinical information.\n- Please retain this letter with your laboratory records and forward this leer to those who may have received this product.",
      "product_quantity": "23 units",
      "distribution_pattern": "US Nationwide distribution in the states of Arizona, California, Florida, Indiana, Kansas, Kentucky, Maryland, Massachusetts, Minnesota, New Jersey, Pennsylvania, Texas, Washington.",
      "openfda": {
        "k_number": [
          "K252163",
          "K261686",
          "K242706",
          "K253240"
        ],
        "registration_number": [
          "3002895169",
          "9615837",
          "2521625",
          "9610126"
        ],
        "fei_number": [
          "3002608770",
          "3002806559",
          "2521625",
          "3002895169"
        ],
        "device_name": "Immunoassay Blood Test For Amyloid Pathology Assessment",
        "medical_specialty_description": "Immunology",
        "regulation_number": "866.5840",
        "device_class": "2"
      }
    }
  ]
}