{
  "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": "44141",
      "product_res_number": "Z-0606-06",
      "event_date_initiated": "2006-02-09",
      "event_date_posted": "2006-03-15",
      "recall_status": "Terminated",
      "event_date_terminated": "2006-08-23",
      "res_event_number": "34586",
      "product_code": "MVC",
      "pma_numbers": [
        "P040030"
      ],
      "product_description": "Test kit used in the assessment of breast cancer patients for whom Herceptin therapy is being considered.  BioGenex brand InSite HER-2/neu IHC Kit, Manual;\nModel Numbers: RD134-60K;\nLot Numbers: RD1340205, RD1340205X, RD1340205Y",
      "code_info": "Lot Numbers: RD1340205, RD1340205X, RD1340205Y",
      "firm_fei_number": "2936532",
      "recalling_firm": "Biogenex Laboratories",
      "address_1": "4600 Norris Canyon Rd",
      "city": "San Ramon",
      "state": "CA",
      "postal_code": "94583-1320",
      "reason_for_recall": "Products produce granular staining in immunostained tissue sections, which may lead to misdiagnosis due to false positive result.",
      "root_cause_description": "Other",
      "action": "On 2/9/06, the firm issued letters via UPS to all of its  consignees, informing them of the affected products and providing instructions on the recall.",
      "product_quantity": "14 units",
      "distribution_pattern": "Nationwide. Italy, and United Kingdom.\nThe product was released for distribution to 21 consignees nationwide to CA, FL, GA, IA, IL, NC, NJ, NY, TX, VT, WA, and WI.\n\nOne VA account: VA Medical Center, Gwen Levy, Bld. 500, Room 1238, 11301 Wilshire Blvd., Los Angeles, CA 90073.\n\n2 overseas consignees distributed the product to Italy (Space Imports Export SPL, Via Ranzato, 12, 1-20128 Milano, Italy and United Kingdom (Launch Diagnosis, West Yoke Farm unit 11, Michaels, Lane, Sevenoaks, Kent, TN15 7EP United Kingdom",
      "openfda": {
        "pma_number": [
          "P040030",
          "P090015",
          "P990081",
          "P980018"
        ],
        "registration_number": [
          "3013059683",
          "3009189893",
          "3004859032",
          "2028492",
          "9610099",
          "3004140393",
          "3003423869"
        ],
        "fei_number": [
          "3002806778",
          "1000125183",
          "3013059683",
          "3009189893",
          "3004859032",
          "3004140393",
          "3003423869"
        ],
        "device_name": "System, Test, Her-2/Neu, Ihc",
        "medical_specialty_description": "Unknown",
        "regulation_number": "",
        "device_class": "3"
      }
    }
  ]
}