{
  "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": "2026-09-17",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "197520",
      "product_res_number": "Z-1016-2023",
      "event_date_initiated": "2022-12-06",
      "event_date_posted": "2023-01-25",
      "recall_status": "Open, Classified",
      "res_event_number": "91344",
      "product_code": "CEW",
      "k_numbers": [
        "K000471"
      ],
      "product_description": "Future Diagnostics STAT-IntraOperative-Intact-PTH (STAT-IO-I-PTH) Immunoassay kit REF 4K-IPT-00. in vitro diagnostic.",
      "code_info": "Catalog Number: 4K-IPT-00\nUDI-DI: 08719326045214-230915\nLot Numbers:\nM78559\nM78560\nM78636",
      "firm_fei_number": "3001857593",
      "recalling_firm": "Future Diagnostics Solutions B.V.",
      "address_1": "Nieuweweg 279 279 nieuweweg",
      "city": "Wijchen",
      "country": "Netherlands",
      "reason_for_recall": "Due to an issue of high coefficient of variability (CV) problem caused by the accuspheres inside the Immunoassay kits.",
      "root_cause_description": "Under Investigation by firm",
      "action": "On 12/06/2022, the firm send a Recall Notice via email to customer informing them that The PTH kit 4K-IPT-00 with lot numbers: M78559, M78560 and M78636 can occasionally give a high duplicate %CV outside the recommended maximum of 15%CV.  As a result of the failure in the duplicate CV requires a repeat run it may cause a delay in the patient result turnaround time or in system calibration depending on what samples are run and can lead to a wrong sample result.\n\nActions to be taken by customers:\n-Immediately identify and quarantine the affected lot numbers.\n-Further instructions will be provided by the Future Diagnostics.\n\nFor questions, send an email to fieldsafety@future-diagnostics.nl.",
      "product_quantity": "342 kits",
      "distribution_pattern": "Worldwide distribution.  US states of AZ, CA, CO, LA, OH, PA, and TX; Austria, Denmark, France, Germany, Greece, Ireland, Italy, Netherlands, Spain, Sweden, and United Kingdom",
      "openfda": {
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        "registration_number": [
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        "fei_number": [
          "3007111389",
          "3011989923",
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          "3007981058",
          "2432235",
          "3002806557",
          "1000121039"
        ],
        "device_name": "Radioimmunoassay, Parathyroid Hormone",
        "medical_specialty_description": "Clinical Chemistry",
        "regulation_number": "862.1545",
        "device_class": "2"
      }
    }
  ]
}