{
  "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": "2026-05-06",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Branchburg",
      "state": "NJ",
      "country": "United States",
      "classification": "Class III",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "63310",
      "recalling_firm": "Roche Molecular Systems, Inc.",
      "address_1": "1080 Us Highway 202 S",
      "address_2": "N/A",
      "postal_code": "08876-3733",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "E-Mail",
      "distribution_pattern": "Worldwide Distribution -   Australia, Austria,  Belgium, China, Hungary, Turkey and United Kingdom.",
      "recall_number": "Z-0188-2013",
      "product_description": "cobas 4800 BRAF V600 Mutation Test for In Vitro Diagnostic Use Roche Molecular Systems, Inc.,     Product Usage:  The primary use of the cobas 4800 BRAF V600 Mutation Test is the detection of the BRAF V600 mutations in DNA extracted from formalin-fixed, paraffin-embedded human melanoma tissue. It is intended to be used as an aid in selecting melanoma patients whose tumors carry BRAF V600 mutations for treatment with Zelboraf (vemurafenib).",
      "product_quantity": "44 kits",
      "reason_for_recall": "It was identified that BRAF controls dispositioned as \"Internal Use Only\" were incorrectly packaged into cobas 4800 BRAF V600 Mutation Test CE-IVD kit lot R03607 and released for distribution.  Two control batches manufactured during two process validation studies are involved:    PV7711: BRAF Mutant (MUT) Control  PV0853: BRAF Wild Type (WT) Control",
      "recall_initiation_date": "20120731",
      "center_classification_date": "20121101",
      "termination_date": "20130911",
      "report_date": "20121107",
      "code_info": "Material number 05985595190; Lot number R03607",
      "more_code_info": ""
    }
  ]
}