{
  "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": "2026-08-22",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "38786",
      "product_res_number": "Z-0866-05",
      "event_date_initiated": "2005-04-18",
      "event_date_posted": "2005-06-04",
      "recall_status": "Terminated",
      "event_date_terminated": "2005-10-13",
      "res_event_number": "31942",
      "product_code": "LEG",
      "k_numbers": [
        "K042476"
      ],
      "product_description": "VITROS VALP Reagent , REF 680 1710.  Each box contains 6 packs.  Each pack contains liquid reagent for 50 tests.  Responsible firm on the label:  Ortho-Clinical Diagnostics, Inc., Rochester, N.Y.  14626.",
      "code_info": "01-5871, Exp. 31Jan06",
      "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 may be observed when the reagent is stored on the VITROS 5,1FS Chemistry System for less than seven days.",
      "root_cause_description": "Other",
      "action": "Letters dated 4/18/2005 with instructions to process a mid-level QC fluid every eight hours when processing patient samples for valproic acid. Replacement product to be shipped as soon as available.",
      "product_quantity": "139 boxes",
      "distribution_pattern": "37 U.S. consignees nationwide.   \nOrtho-Clinical foreign affiliates in England, France and Spain.",
      "openfda": {
        "k_number": [
          "K031870",
          "K862652",
          "K801207",
          "K925003",
          "K941615",
          "K961256",
          "K934061",
          "K060690",
          "K090358",
          "K000005",
          "K895569",
          "K030405",
          "K803236",
          "K953224",
          "K943866",
          "K002551",
          "K032049",
          "K011649",
          "K832719",
          "K964442",
          "K011947",
          "K042807",
          "K982880",
          "K901538",
          "K822933",
          "K922844",
          "K830789",
          "K936208",
          "K961988",
          "K891581",
          "K972132",
          "K930734",
          "K911688",
          "K973581",
          "K042476"
        ],
        "registration_number": [
          "1036362",
          "3006198300",
          "2250051",
          "2050012",
          "9610126",
          "1319808",
          "3002642396",
          "3003561301",
          "3000308930",
          "2050010",
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          "3010825766",
          "1319681",
          "3010939897",
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          "3012963943",
          "3002806944",
          "2517506",
          "3002809144",
          "3004493545",
          "3003795116",
          "9610529"
        ],
        "fei_number": [
          "3002806560",
          "3002806559",
          "1036362",
          "3006198300",
          "2250051",
          "1000305841",
          "3002642396",
          "3003561301",
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          "3005333358",
          "3010825766",
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          "3003871639",
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          "3012963943",
          "3002806944",
          "2517506",
          "3002809144",
          "3004493545",
          "3003795116",
          "1000136573",
          "2050012"
        ],
        "device_name": "Enzyme Immunoassay, Valproic Acid",
        "medical_specialty_description": "Clinical Toxicology",
        "regulation_number": "862.3645",
        "device_class": "2"
      }
    }
  ]
}