{
  "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": "2026-09-20",
    "results": {
      "skip": 0,
      "limit": 1,
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    }
  },
  "results": [
    {
      "cfres_id": "199424",
      "product_res_number": "Z-1396-2023",
      "event_date_initiated": "2023-03-09",
      "event_date_posted": "2023-04-18",
      "recall_status": "Open, Classified",
      "res_event_number": "92017",
      "product_code": "QKO",
      "product_description": "VITROS Immunodiagnostic Products Anti-SARSCoV- 2 Total N Antibody\nCalibrators programmed onto the Assay Data Disks (ADD) Data Release Versions (DRV):\nDRVs 6213 through 6218 supporting VITROS Calibrators.\nProduct Code: 6199976",
      "code_info": "UDI: 10758750034581\nLot # /Expiration Date:\n0230   22-Feb-2023;\n0240   22-Mar-2023;\n0250   26-Apr-2023.",
      "firm_fei_number": "2250051",
      "recalling_firm": "Ortho-Clinical Diagnostics, Inc.",
      "address_1": "1001 Us Highway 202",
      "city": "Raritan",
      "state": "NJ",
      "postal_code": "08869-1424",
      "additional_info_contact": "SAME\n908-218-8776",
      "reason_for_recall": "Incorrect Number of Calibrator Levels (2) Set for the VITROS Immunodiagnostics Products Anti-SARS-CoV-2 Total N Antibody Calibrators in Assay Data Disks (ADD),\nresulting in delayed patients results",
      "root_cause_description": "Employee error",
      "action": "Ortho Clinical Diagnostics issued  Important Product Correction Notification letter on 3/9/23. Letter states reason for recall, health risk and action to take:\n To calibrate all lots currently within expiring date of Anti-SARS-CoV-2 Total N, load ADD 6219 or higher on your VITROS System.\n\" Complete the enclosed Confirmation of Receipt form no later than March 17, 2023.\n\" Please forward this notification and ADD if the affected product was distributed outside of your facility.\n\" If your laboratory has experienced the issue with this product and you have not already done so, please report the occurrence to your local Ortho Care\" Technical Solutions Center.\n If you have further questions, please contact Ortho Care Technical Solutions Center at 1-800-421-3311.",
      "product_quantity": "256 units",
      "distribution_pattern": "US Nationwide distribution in the states of AL, AZ, CA,  GA, NY.",
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        "device_name": "Reagent, Coronavirus Serological",
        "medical_specialty_description": "Unknown",
        "regulation_number": "",
        "device_class": "N"
      }
    }
  ]
}