{
  "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": "N/A",
      "country": "France",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "78387",
      "recalling_firm": "BioMerieux SA",
      "address_1": "Chemin De L'Orme",
      "address_2": "N/A",
      "postal_code": "N/A",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Distributed domestically to MD, CO, and OH.",
      "recall_number": "Z-0086-2018",
      "product_description": "NucliSENS Lysis Buffer    Extended lot for RES 76675",
      "product_quantity": "911 units",
      "reason_for_recall": "Elute may become colored due to the residual presence of heme group origination from hemoglobin present in whole blood samples as well as dried spot (DBS) samples.  This can potentially cause the inhibition of PCR reactions and result in an uninterpretable test result.  If using an Internal Control (IC) in the extraction process the IC could potentially be inhibited as well and invalidate test results.",
      "recall_initiation_date": "20171018",
      "center_classification_date": "20171109",
      "termination_date": "20210824",
      "report_date": "20171115",
      "code_info": "REF 200292, Lot 17022802, Exp Date 01/28/2019    Extended lot for RES 76675"
    }
  ]
}