{
  "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": "2026-08-27",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "124095",
      "product_res_number": "Z-0557-2014",
      "event_date_initiated": "2013-10-25",
      "event_date_posted": "2013-12-20",
      "recall_status": "Terminated",
      "event_date_terminated": "2018-05-18",
      "res_event_number": "66900",
      "product_code": "LOM",
      "pma_numbers": [
        "P000014",
        "P000014S025"
      ],
      "product_description": "VITROS Anti-HBs Calibrators & VITROS Anti-HBs Reagent Packs",
      "code_info": "Product Code 1) 6801926, 2) 6801925, 3) 6802452 Lot numbers: 1) 6700, 2) 6731, 3) 6830 Expiry Dates: 1) 21 May 2013, 2) 24 July 2013, 3) 11 Sept 2013",
      "firm_fei_number": "1000136573",
      "recalling_firm": "Ortho-Clinical Diagnostics",
      "address_1": "100 Indigo Creek Dr",
      "city": "Rochester",
      "state": "NY",
      "postal_code": "14626-5101",
      "reason_for_recall": "Ortho Clinical Diagnostics issued a Product Correction Notification for VITROS Immunodiagnostic Products Anti-HBs Calibrators and Anti-HBs Quantitative Reagent Packs due to false positive results.",
      "root_cause_description": "Other",
      "action": "On October 25, 2013, Ortho Clinical Diagnostics issued product correction notifications to their US customers via US Postal Service Priority Mail and email notices to their foreign affiliates informing  them of the recall.  Ortho Clinical Diagnostics advised their customers to review previously reported results between > 12 and <30 mIU/mL and consult the Laboratory Medical Director.  Customers were instructed to utilize alternative methods for anti-HBs testing.  Customers are advised to seek alternative methods for anti-HBs testing.  For additional information, please contact the OCD Customer Technical Service representative at 1-800-421-3311.",
      "product_quantity": "1,920 kits",
      "distribution_pattern": "Nationwide distribution - all states.",
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        ],
        "device_name": "Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)",
        "medical_specialty_description": "Microbiology",
        "regulation_number": "866.3172",
        "device_class": "2"
      }
    }
  ]
}