{
  "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": "140615",
      "product_res_number": "Z-0171-2016",
      "event_date_initiated": "2015-09-30",
      "event_date_created": "2015-11-04",
      "recall_status": "Terminated",
      "event_date_terminated": "2016-10-18",
      "res_event_number": "72321",
      "product_code": "LIZ",
      "k_numbers": [
        "K842218"
      ],
      "product_description": "BD CD3 (SK7) FITC; IVD;  Catalog # 349201 and 340542\n\nHematology: The CD3 antibody reacts with the epsilon chain of the CD3 antigen/T-cell antigen receptor (TCR) complex.  In vitro diagnostic.",
      "code_info": "Catalog Number: 349201; Lot Number 5148598 (expires 10-31-2016) Catalog Number: 340542; Lot Number 5113983 (expires 02-28-2017)",
      "firm_fei_number": "2916837",
      "recalling_firm": "Becton, Dickinson and Company, BD Biosciences",
      "address_1": "2350 Qume Dr",
      "city": "San Jose",
      "state": "CA",
      "postal_code": "95131-1812",
      "additional_info_contact": "Melissa J. Quinn\n408-954-6080",
      "reason_for_recall": "Two lots of CD3 (SK7) FITC label contains an error in the Spanish Small text.",
      "root_cause_description": "Under Investigation by firm",
      "action": "BD sent an \"URGENT PRODUCT RECALL\" letter dated September 30, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer.\n\nCustomer Actions: \n\n1. Discard all remaining stock of CD3 (SK7) FITC, catalog number 349201, lot number 5148598, and/or catalog number 340542, lot number 5113983, and request replacement product. BD will replace  product at no cost.\n\n2.As a requirement of our Regulatory Tracking Process, we request that you complete the enclosed Tracking Verification form, even if you no longer have the affected reagents listed in your inventory. Please return the Tracking Verification form to BD Biosciences, per the instructions  (mail, fax, or email).\n\nWe apologize for any inconvenience that this may have caused and are working toward a long-term solution to this issue. If you require further assistance, please contact BD Customer Support at 877.232.8995 (prompt  3, 3) in the United States. For customers outside the US, contact your local BD Biosciences representative  or distributor.",
      "product_quantity": "120 units",
      "distribution_pattern": "US (nationwide) Distribution to the states of : TX, GA, IN, TN, CA, KY, WA, IL, MO, NY, CT, MN, NV, KS, WI, NH, FL, PA, OH, OR, SC. OK, NC and LA., and Internationally to Mexico.",
      "openfda": {
        "k_number": [
          "K831053",
          "K820643",
          "K914847",
          "K842218",
          "K833929",
          "K843062",
          "K860830"
        ],
        "device_name": "Assay, T Lymphocyte Surface Marker",
        "medical_specialty_description": "Hematology",
        "regulation_number": "864.5220",
        "device_class": "2",
        "registration_number": [
          "3027394506",
          "3008352382"
        ],
        "fei_number": [
          "3027394506",
          "3008352382"
        ]
      }
    }
  ]
}