{
  "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": "42548",
      "product_res_number": "Z-0137-06",
      "event_date_initiated": "2005-09-29",
      "event_date_posted": "2005-11-15",
      "recall_status": "Terminated",
      "event_date_terminated": "2007-07-31",
      "res_event_number": "33848",
      "product_code": "KHO",
      "k_numbers": [
        "K962919"
      ],
      "product_description": "Vitros ECi Immunodiagnostic System, sold as Cat. #863 3893; Cat. #192 2814 (Vitros ECiQ), and Cat. #680 1059 (recertified Vitros ECi)  when using Vitros Anti-HBc IgM Reagent Packs and Anti-HAV IgM Reagent Packs.  NOTE:  These 3 catalog numbers of Vitros ECi represent the original unit, an updated unit with cosmetic changes only, and refurbished units.",
      "code_info": "All Vitros ECi units currently on the market (software version 3.1 or lower).",
      "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": "Judy M. Strzepek\n908-218-8524",
      "reason_for_recall": "When using Vitro ECi Immunodiagnostic System with Vitros Anti-HBc IgM Reagent Packs and Anti-HAV IgM Reagent Packs, results of the 1st of  two required re-test replicates may be negtively biased.",
      "root_cause_description": "Other",
      "action": "Letters dated 9/29/2005 issued to all domestic customers of the VITROS ECi/ECiQ systems and to Ortho/J&J foreign affiliates.  Customers instructed to immediately discontinue using reflex processing  to the VITROS Anti-HBc IgM and VITROS Anti-HAV reagent packs.",
      "product_quantity": "3,507 Vitros ECi units distributed",
      "distribution_pattern": "Nationwide and worldwide distribution of the VITROS ECi Immunodiagnostic systems.",
      "openfda": {
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        ],
        "device_name": "Fluorometer, For Clinical Use",
        "medical_specialty_description": "Clinical Chemistry",
        "regulation_number": "862.2560",
        "device_class": "1"
      }
    }
  ]
}