{
  "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": "2026-04-08",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Durham",
      "state": "NC",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "79993",
      "recalling_firm": "bioMerieux, Inc.",
      "address_1": "100 Rodolphe St",
      "address_2": "",
      "postal_code": "27712-9402",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Worldwide Distribution - US Nationwide in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, VA, VT, WA, WI, WV, WY.      International distribution to Algeria, Angola, Anguilla, Argentina, Armenia, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belarus, Belgium, Benin, Bolivia, Bosnia - Herzegovina, Brazil, Brunei, Bulgaria, Burkina Faso, Cambodia, Cameroon, Canada, Cape Verde, Chad, Chile, China / Hong Kong, Colombia, Congo, Costa Rica, Croatia, Czech Republic, Denmark, Djibouti, Dominican Republic, Dutch Antilles, Ecuador, Egypt, El Salvador, Estonia, Ethiopia, Finland, France, Gabon, Georgia, Germany, Ghana, Greece, Guam, Guatemala, Guinea, Honduras, Hungary, India, Indonesia, Iran, Iraq, Israel, Italy, Ivory Coast, Japan, Jordan, Kazakhstan, Kenya, Kuwait, Latvia, Lebanon, Libya, Lithuania, Macedonia, Malaysia, Mali, Malta, Mauretania, Mexico, Mongolia, Morocco, Mozambique, Myanmar, Nepal, Netherlands, Nicaragua, Niger, Nigeria, Norway, Oman, Pakistan, Palestine, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russian Fed., Saudi Arabia, Senegal, Serbia, Singapore, Slovenia, South Africa, South Korea, Spain, Sri Lanka, Sudan, Sweden, Switzerland, Syria, Tanzania, Thailand, Togo, Tunisia, Turkey, Turkmenistan, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Uzbekistan, Venezuela, Vietnam, Zimbabwe.",
      "recall_number": "Z-2429-2018",
      "product_description": "BioMerieux VIDAS System in combination with Quality Control VIDAS* (QCV*)    Product Usage:  the Quality Control VIDAS (QCV) is an automated test for use on the VIDAS¿ system to detect abnormal operation of the VIDAS and mini VIDAS instrument pipette mechanisms and optical systems. Specifically the mini VIDAS system is an immunodiagnostic system intended to be used by trained and qualified laboratory professionals, for In vitro Diagnostic (IVD) purpose, veterinary and industrial applications. The mini VIDAS¿ system is intended to execute an immunoassay protocol and to release results according to the package insert of the VIDAS¿ assay kits.",
      "product_quantity": "1,866 units",
      "reason_for_recall": "Increase of events affecting performance regarding pump clogging and displacement of the color-coded SPR label (DOT).  These performance issues could contribute to erroneous results for any assay performed on the VIDAS¿ and mini VIDAS¿ system due to a decrease of pipetted volume.",
      "recall_initiation_date": "20180104",
      "center_classification_date": "20180712",
      "termination_date": "20220414",
      "report_date": "20180718",
      "code_info": "Description, Reference No. (UDI No.):  VIDAS ANALYSER 110/220V, 93296 (03573026133573); VIDAS ANALYSER 220V, 93297 (03573026133580); VIDAS ANALYSEUR, 99011 (03573026109257); VIDAS ANALYSER EU, 99444 (03573026114060); VIDAS ANALYSER US, 99445 (03573026114084); VIDAS ANALYSER, 99735 (03573026140427); VIDAS ANALYSER US, W2205 (03573026029678); VIDAS ANALYSER, 410417 (03573026351663); Quality Control VIDAS¿ (QCV), 30706 (03573026121631); VIDAS ANALYSER EU, W3205 (03573026030292); VIDAS INDUSTRY US, 421002 (03573026553319)",
      "more_code_info": ""
    }
  ]
}