{
  "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": "2026-04-15",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Marcy L'Etoile",
      "state": "",
      "country": "France",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "79620",
      "recalling_firm": "BioMerieux SA",
      "address_1": "Chemin De L'Orme",
      "address_2": "",
      "postal_code": "N/A",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Distribution was made to the recalling firm's distribution center in KY.  There was no military/government distribution.",
      "recall_number": "Z-2331-2018",
      "product_description": "VIDAS FSH, Ref 30407-01, IVD, Rx.  The firm name on the label is bioMerieux SA, France.    For use on the instruments of the VIDAS family (VITEK ImmunoDiagnostic Assay System) as an automated quantitative enzyme-linked fluorescent immunoassay (ELFA) for the determination of human follicle stimulating hormone (FSH) concentration in human serum or plasma (heparin). It is intended for use as an aid in the diagnosis of pituitary gland and gonadal disorders.",
      "product_quantity": "59 units distributed to the U.S.",
      "reason_for_recall": "Invalid calibration with low calibrator S1 while using the product.",
      "recall_initiation_date": "20180409",
      "center_classification_date": "20180628",
      "termination_date": "20251202",
      "report_date": "20180704",
      "code_info": "Lot #1005888210 was distributed in the U.S.",
      "more_code_info": ""
    }
  ]
}