{
  "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": "2026-08-20",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "48146",
      "product_res_number": "Z-0077-2007",
      "event_date_initiated": "2006-03-06",
      "event_date_posted": "2006-10-27",
      "recall_status": "Terminated",
      "event_date_terminated": "2008-06-18",
      "res_event_number": "36184",
      "product_code": "JQP",
      "product_description": "VITROS WorkCentre, Catalog # 6802159, using enGen\" Series Automation Systems (Catalog # ENGEN). VITROS WorkCentre is Ortho-Clinical Diagnostics, Inc.''s branded version of Instrument Manager\" developed & listed by Data Innovations, Inc. of South Burlington, VT. --- Ortho-Clinical Diagnostics, Rochester, NY.",
      "code_info": "Catalog # 6802159",
      "firm_fei_number": "1000136573",
      "recalling_firm": "Ortho-Clinical Diagnostics",
      "address_1": "100 Indigo Creek Drive",
      "city": "Rochester",
      "state": "NY",
      "postal_code": "14626",
      "additional_info_contact": "Mr. Joseph Falvo\n585-453-5735",
      "reason_for_recall": "Incorrect result calculations can occur (only affects derived results calculated by the VITROS WorkCentre)",
      "root_cause_description": "Other",
      "action": "On 3/06/06, all domestic end-users were sent \"URGENT PRODUCT CORRECTION NOTIFICATION\" letters (dated 3/06/06) by fax and FedEx, informing the users of the problem. The users were also notified by phone. OCD also notified its affiliates in France and the UK of the issue for notifying their customers of the problem.",
      "product_quantity": "3 Domestic, 6 Foreign",
      "distribution_pattern": "Worldwide distribution ---- USA including states of DE, TN, MI, and AZ and countries of United Kingdom and France.",
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