{
  "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": "50913",
      "product_res_number": "Z-0735-2007",
      "event_date_initiated": "2007-03-09",
      "event_date_posted": "2007-04-11",
      "recall_status": "Terminated",
      "event_date_terminated": "2007-08-23",
      "res_event_number": "37585",
      "product_code": "NTI",
      "product_description": "AmpliChip CYP450 Test, CE-IVD, M/N: 4381866190, Roche Molecular Systems, Inc.",
      "code_info": "European Distribution: Model number 4381866190  (CE-IVD) Batches: H08500, H13591, H14242, J00383, J00814",
      "firm_fei_number": "2243471",
      "recalling_firm": "Roche Molecular Systems, Inc.",
      "address_1": "1080 US Highway 202 S",
      "city": "Somerville",
      "state": "NJ",
      "postal_code": "08876-3733",
      "additional_info_contact": "Vincent C. Stagnitto\n908-253-7569",
      "reason_for_recall": "The current package insert for the AmpliChip CYP 450 test, lists an incorrect part number for DNase I.  The DNase is listed in the \"Other Materials Required\" section as 'DNase I rec., RNase-free, P/N 04716728001 (Roche Applied Science)\" .  The Part Number listed for the DNase I listed is incorrect and  of lower specific activity than the correct/validated DNase.",
      "root_cause_description": "Other",
      "action": "A product advisory notice was issued on March 9, 2007 to all affiliates,  indentifying the problem and listing corrective actions followed by a customer letter (Urgent Medical Device Correction) issued on 3/21/2007, requesting several actions be performed including discontinued use of incorrect DNAse I.",
      "product_quantity": "89",
      "distribution_pattern": "World wide Distribution --- USA including states of MI, IN, NC, CA KY, IN, VA, and FL.and countries of Netherlands, Germany, Sweden, Denmark, Italy, Spain, Belgium, Switzerland, and Hungary",
      "openfda": {
        "k_number": [
          "K131565",
          "K051824",
          "K123891",
          "K101683",
          "DEN040011",
          "K093420",
          "K043576",
          "K130189",
          "K170492",
          "K220026",
          "K120466"
        ],
        "registration_number": [
          "3002777243",
          "3021047648",
          "3005406097"
        ],
        "fei_number": [
          "3002777243",
          "3021047648",
          "3005406097"
        ],
        "device_name": "Drug Metabolizing Enzyme Genotyping Systems",
        "medical_specialty_description": "Clinical Toxicology",
        "regulation_number": "862.3360",
        "device_class": "2"
      }
    }
  ]
}