{
  "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": "2026-04-15",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "country": "United States",
      "city": "San Jose",
      "address_1": "2350 Qume Dr",
      "reason_for_recall": "Internal review found that some vials of CD3/CD4/CD45 state that the product contains gelatin. The product does not contain gelatin and should state in buffer.",
      "address_2": "",
      "product_quantity": "14,089",
      "code_info": "Catalog number: 340383;  lot No.      Expiration Date  49983,      31 July 2016;  01810,      30 September 2016;  82527,      30 September 2016;  54689 ,     30  November 2016;  36715 ,     31 December 2016;  15614,      31 January 2017;  57797,      28 February 2017.",
      "center_classification_date": "20160809",
      "distribution_pattern": "Nationwide distribution to AR, CA, CO, IL, IN, LA, MA, MD, Ml, MN, NC, NJ, NM, NY, OR, PA, TN, TX, WA",
      "state": "CA",
      "product_description": "BD Tritest CD3 FITC/CD4 PE/CD45 PerCP (IVD);  Catalog number 340383.  Label states: Contains CD3 FITC/CD4 PE/CD45 per CP with Gelatin and 0.1% sodium azide.      Hematology:  BD Tritest CD3 fluorescein isothiocyanate (FITC)/CD4 phycoerythrin (PE)/CD45 peridinin chlorophyll protein (PerCP) is a three-color direct immunofluorescence reagent for use with a suitably equipped flow cytometer to identify and determine the percentages and absolute counts of mature human T lymphocytes (CD3+) and helper/inducer (CD3+CD4+) Tlymphocyte  subsets in erythrocyte-lysed whole blood.",
      "report_date": "20160817",
      "classification": "Class III",
      "openfda": {},
      "recalling_firm": "Becton, Dickinson and Company, BD Biosciences",
      "recall_number": "Z-2378-2016",
      "initial_firm_notification": "Letter",
      "product_type": "Devices",
      "event_id": "74788",
      "termination_date": "20170301",
      "more_code_info": "",
      "recall_initiation_date": "20160718",
      "postal_code": "95131-1812",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Terminated"
    }
  ]
}