{
  "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": "2026-08-15",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "30719",
      "product_res_number": "Z-0298-04",
      "event_date_initiated": "2003-11-26",
      "event_date_posted": "2004-01-06",
      "recall_status": "Terminated",
      "event_date_terminated": "2004-02-20",
      "res_event_number": "27905",
      "product_code": "JHX",
      "k_numbers": [
        "K993068"
      ],
      "product_description": "Vitros Immunodiagnostic Products CK-MB REAGENT PACK, REF 189 6836, 100 coated wells per pack.  Firm on the label:  Ortho-Clinical Diagnostics, Amersham, UK.",
      "code_info": "Lot 611, Exp. 25 June 2004",
      "firm_fei_number": "1000136573",
      "recalling_firm": "Ortho-Clinical Diagnostics",
      "address_1": "100 Indigo Creek Drive",
      "city": "Rochester",
      "state": "NY",
      "postal_code": "14650-0881",
      "additional_info_contact": "Sherry L. Phillips\n585-453-7328",
      "reason_for_recall": "Reagent packs may contain wells that produce a low light signal that could result in calibration failures or negatively biased results.",
      "root_cause_description": "Other",
      "action": "Customers notified via phone and faxed letter on 11/26/03.  Customers provided with a modified QC procedure to be used until new shipments can be made.",
      "product_quantity": "774 reagent packs",
      "distribution_pattern": "738 reagent packs shipped to U.S. consignees and 36 reagent packs to Canadian consignees.",
      "openfda": {
        "k_number": [
          "K993068",
          "K801318",
          "K913298",
          "K771605",
          "K881267",
          "K802826",
          "K981099",
          "K813573",
          "K984067",
          "K792504",
          "K022118",
          "K980012",
          "K874144",
          "K994439",
          "K870987",
          "K800544",
          "K890543",
          "K041596",
          "K163462",
          "K033747",
          "K234005",
          "K771324",
          "K973126",
          "K813087",
          "K913380",
          "K790294",
          "K991797",
          "K812759",
          "K873171",
          "K004002",
          "K962549",
          "K791582",
          "K000716",
          "K873399",
          "K030012",
          "K212648",
          "K034055",
          "K120326",
          "K760591",
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          "K051650",
          "K840549",
          "K801728",
          "K881237",
          "K013118",
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        "registration_number": [
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        "fei_number": [
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          "2517506",
          "3003366417",
          "3002806944",
          "3006198300"
        ],
        "device_name": "Fluorometric Method, Cpk Or Isoenzymes",
        "medical_specialty_description": "Clinical Chemistry",
        "regulation_number": "862.1215",
        "device_class": "2"
      }
    }
  ]
}