{
  "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": "2026-04-22",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Branchburg",
      "state": "NJ",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "74221",
      "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": "Letter",
      "distribution_pattern": "Foriegn Distribution       Austria, Belgium, Croatia, Czech  Republic, Denmark, France, Germany,  Greece, Hungary , Italy, Lithuania,  Luxembourg, Netherlands, Norway, Poland,  Romania, Slovakia, Slovenia, Spain,  Switzerland, Turkey, United Kingdom  cfDNA: Austria, Belgium, Croatia, Czech  Republic, Denmark, France, Germany,  Greece, Hungary , Italy, Lithuania,  Luxembourg, Netherlands, Poland,  Romania, Slovakia, Slovenia, Spain,  Switzerland, Turkey, United Kingdom",
      "recall_number": "Z-2254-2016",
      "product_description": "cobas EGFR Mutation Test V2  Materials number   CE-IVD: EGFR v2: 07248563190  cfDNA: 07247737190    Device Identifier:  EGFR v2.0: 00875197005448  cfDNA: 00875197005424    Product Usage:  A real time PCR Test for the qualitative detection and identifications of mutations n exons 18, 19, 20 and 21 of the epidermal growth factor receptor (EGFR) gene in DNA derived from formalin-fixed paraffin-embedded (FFPET) tumor tissue or plasma from non-small cell lung cancer (NSCLC) patients. The test also is intended to be used as an aid in selecting patients with NSCLC for therapy with an EGFR tyrosine kinase inhibitor (TKI).",
      "product_quantity": "735 devices EGFR; 509 devices cfDNA",
      "reason_for_recall": "During internal studies using contrived plasma specimens, several mutations (L8568R, Exon 19 deletion, T790M) inconsistently generated \"No Mutation Detected\" (ie False Negative ) result with the cobas EGFR mutation Text V2.0 when utilizing the cobas cfDNA Sample Preparation kit.",
      "recall_initiation_date": "20160405",
      "center_classification_date": "20160721",
      "termination_date": "20171211",
      "report_date": "20160727",
      "code_info": "Lot W08792, Lot W11783, Lot W11438, Lot W14903, Lot W05108. Lot W11435, Lot W12238",
      "more_code_info": ""
    }
  ]
}