{
  "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": "42702",
      "product_res_number": "Z-0173-06",
      "event_date_initiated": "2005-10-12",
      "event_date_posted": "2005-11-18",
      "recall_status": "Terminated",
      "event_date_terminated": "2008-09-22",
      "res_event_number": "33896",
      "product_code": "LEH",
      "k_numbers": [
        "K043386"
      ],
      "product_description": "VITROS VANC (vancoymycin) Reagent, REF #680 1709.  Firm on label:  Ortho-Clinical Diagnostics, Inc., Rochester, NY  14626",
      "code_info": "01-5919, Exp. 5/31/2005 (EXPIRED):  01-6032, Exp. 9/30/2005 (EXPIRED); and 02-6284, Exp. 1/28/2006",
      "firm_fei_number": "1000136573",
      "recalling_firm": "Ortho-Clinical Diagnostics",
      "address_1": "100 Indigo Creek Dr",
      "city": "Rochester",
      "state": "NY",
      "postal_code": "14626-5101",
      "additional_info_contact": "Judy M. Strzepek\n908-218-8524",
      "reason_for_recall": "Negatively biased results can be observed when the reagent pack has less than five tests remaining and has been on the analyzer greater than 2 days.",
      "root_cause_description": "Other",
      "action": "Letters dated 10/12/2005 issued to end users in the U.S.  Customers advised they may continue to use the VANC Reagent if their laboratory processes QC fluids according to protocol.  A return reply form is included.  Foreign affiliates were notified via e-mail on 10/12/2005.",
      "product_quantity": "784 boxes x 6 packs x 50 tests",
      "distribution_pattern": "Product shipped to medical facilities (end-users) in the U.S. and to 9 International J&J affiliates in Australia, Canada, Caribbean, Chile, France, Philippines, Portugal, Taiwan, UK/Northern Europe, Israel, Saudi Arabia and Venezuela.",
      "openfda": {
        "k_number": [
          "K013076",
          "K020692",
          "K152245",
          "K032811",
          "K964587",
          "K123947",
          "K900708",
          "K955716",
          "K822308",
          "K222439",
          "K072036",
          "K901759",
          "K872579",
          "K160202",
          "K945125",
          "K813218",
          "K983280",
          "K953528",
          "K881040",
          "K050419",
          "K955851",
          "K951059",
          "K963267",
          "K060586",
          "K874438",
          "K940595",
          "K924957",
          "K892900",
          "K043386",
          "K821136",
          "K063045"
        ],
        "registration_number": [
          "2432235",
          "1319808",
          "2050012",
          "3010939897",
          "3002642396",
          "3002809144",
          "3006198300",
          "1219913",
          "9610126",
          "1317202",
          "3003561301",
          "2250051",
          "3002806944",
          "2517506",
          "3005755244",
          "8020888",
          "9610746",
          "3000308930",
          "1319681",
          "3005333358",
          "2050010",
          "3012963943",
          "3004493545",
          "9610529",
          "3010825766",
          "3003795116",
          "3033967997"
        ],
        "fei_number": [
          "2432235",
          "3002806559",
          "2050012",
          "3010939897",
          "3002642396",
          "3002809144",
          "3006198300",
          "1219913",
          "1317202",
          "3003561301",
          "3002806560",
          "2250051",
          "3002806944",
          "1000136573",
          "2517506",
          "1000305841",
          "3005755244",
          "3000308930",
          "3005333358",
          "2050010",
          "3007019572",
          "3012963943",
          "3004493545",
          "3002806557",
          "3010825766",
          "3003795116",
          "3033967997"
        ],
        "device_name": "Radioimmunoassay, Vancomycin",
        "medical_specialty_description": "Clinical Toxicology",
        "regulation_number": "862.3950",
        "device_class": "2"
      }
    }
  ]
}