{
  "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": "2026-09-12",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "194342",
      "product_res_number": "Z-1367-2022",
      "event_date_initiated": "2022-05-26",
      "event_date_created": "2022-07-12",
      "recall_status": "Open, Classified",
      "res_event_number": "90408",
      "product_code": "QKO",
      "product_description": "Anti-SARS-CoV-2 IgG Quantitative Reagent Pack- Intended for use on VITROS\nECi/ECiQ/3600 Immunodiagnostic Systems and VITROS 5600/XT 7600 Integrated Systems.\nProduct Code: 6199960",
      "code_info": "UDI-DI :10758750034413.\nAll expired, in-date and future released lots",
      "firm_fei_number": "1000136573",
      "recalling_firm": "Ortho-Clinical Diagnostics, Inc.",
      "address_1": "100 Indigo Creek Dr",
      "city": "Rochester",
      "state": "NY",
      "postal_code": "14626-5101",
      "additional_info_contact": "SAME\n585-453-3000",
      "reason_for_recall": "On-Analyzer Stability (OAS) time, supported for 6 weeks; not 8 weeks as is currently stated in the Instructions For Use (IFU).",
      "root_cause_description": "Incorrect or no expiration date",
      "action": "Ortho Clinical Diagnostics issued Important Correction Notification letter (CL2022-135) on May 26, 2022. Letter states reason for recall, health risk and action to take:\nWhen using VITROS Anti-SARS-CoV-2 IgG Quantitative Reagent Pack, do not store\non-analyzer for longer than 6 weeks.\n\" Until a lot update occurs, OAS for VITROS Anti-SARS-CoV-2 IgG Quantitative Reagent Pack will temporarily require manual monitoring and removal of reagent packs from analyzer no longer than 6 weeks after packs have been opened and loaded onto the analyzer.\n\" Complete the enclosed Confirmation of Receipt form no later than June 9, 2022.\n\" Post this notification by each VITROS ECi/ECiQ/3600/5600/XT 7600 System in your\nlaboratory until further notice.\n\" Please forward this notification if VITROS Anti-SARS-CoV-2 IgG Quantitative Reagent Pack was distributed outside of your facility.\n\nIf you have further questions, please contact Ortho Care Technical Solutions Center at 1-800-421-3311",
      "product_quantity": "20858",
      "distribution_pattern": "Worldwide distribution - US Nationwide and the countries of  Colombia, India, Singapore.",
      "openfda": {
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        "device_name": "Reagent, Coronavirus Serological",
        "medical_specialty_description": "Unknown",
        "regulation_number": "",
        "device_class": "N"
      }
    }
  ]
}