{
  "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": "2026-09-10",
    "results": {
      "skip": 0,
      "limit": 1,
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  "results": [
    {
      "cfres_id": "192629",
      "product_res_number": "Z-0946-2022",
      "event_date_initiated": "2022-03-11",
      "event_date_created": "2022-04-15",
      "recall_status": "Open, Classified",
      "res_event_number": "89818",
      "product_code": "REQ",
      "product_description": "Virus Counter Platform with Model Name VC3100",
      "code_info": "Model Numbers VIR-92166, VIR-92341",
      "firm_fei_number": "3010058489",
      "recalling_firm": "Sartorius Corporation",
      "address_1": "6542 Fig St",
      "city": "Arvada",
      "state": "CO",
      "postal_code": "80004-1042",
      "additional_info_contact": "Terri Brooks\n631-469-9877",
      "reason_for_recall": "The Virus Counter is an automated laboratory instrument that enables rapid quantification of intact viruses in solution. This instrument is not a medical device. The virus quantification is used in process development and manufacturing of various biotechnology products such as vaccines, gene therapy and personalized immunotherapy. Device is a Class 1 laser flow cytometer.",
      "root_cause_description": "Radiation Control for Health and Safety Act",
      "action": "Sartorius sent customer notification dated March 11, 2022 to all affected customers. Customers were informed that a field service personnel will be dispatch to update the labeling and provide an updated User Information manual (operator s manual) *. This work occurs at no cost to you regardless of scenario. You need only make the unit accessible for a few minutes for the representative to complete the upgrade.",
      "product_quantity": "82",
      "distribution_pattern": "US Nationwide distribution.",
      "openfda": {
        "device_name": "Laser Rangefinders, Time-Of-Flight Speed Measurement Products",
        "medical_specialty_description": "Unknown",
        "regulation_number": "",
        "device_class": "N"
      }
    }
  ]
}