{
  "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": "2026-04-22",
    "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": "68747",
      "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": "AL, AR, CA, CO, CT, DE, FL, GA, ID, IL, IN, IA, KS, KY, LA, ME, MA, MI, MN, MO, MT, NE, NH, NJ, NY, NC, OH, OK, OR, PA, RI, SC, TN, TX, VT, VA, WA, WV, WI, WY",
      "recall_number": "Z-2232-2014",
      "product_description": "VIDAS D-Dimer Exclusion II, an automated quantitative test for use on instruments of the VIDAS family for the immunoenzymatic determination of fibrin degradation products in human plasma using the Enzyme Linked Fluorescent Assay technique.  Also indicated for use in conjunction with clinical pretest probability assessment model to exclude DVT and PE disease.",
      "product_quantity": "2160 units",
      "reason_for_recall": "Customer complaints about not repeatable results below the detection limit (<45 ng/mL).  Therefore false negatives are being reported for results around the medical decision point of 500 ng/mL that initially tested at <45 ng/mL.",
      "recall_initiation_date": "20130417",
      "center_classification_date": "20140814",
      "termination_date": "20141008",
      "report_date": "20140820",
      "code_info": "Reference 304551-01 - Lots 1001625210, Exp. date 8/8/20123; 1001715580, Exp. date 9/26/2013; 1001711530, Exp. date 9/11/2013; 1001789540, Exp. date 10/29/2013; 1001932680, Exp. date 12/12/2013"
    }
  ]
}