{
  "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": "2026-04-29",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Brea",
      "state": "CA",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "65832",
      "recalling_firm": "Beckman Coulter Inc.",
      "address_1": "250 S Kraemer Blvd",
      "address_2": "N/A",
      "postal_code": "92821-6232",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Worldwide Distribution - USA and the country of Canada.",
      "recall_number": "Z-1997-2013",
      "product_description": "Hemoccult ICT (Immunochemical Fecal Occult Blood Test) is a rapid, visually read, qualitative immunochemical chromatographic method for detection of human hemoglobin in fecal samples.",
      "product_quantity": "68,116 units",
      "reason_for_recall": "Beckman Coulter has received a customer complaint that suggests trending of  positive results has increased from approximately 4% to 1 0%. As a result of our  investigation, Beckman Coulter has confirmed an increase in sensitivity at the  borderline positive level.  \" This testing also demonstrated that the issue does not affect results reported as  negative.",
      "recall_initiation_date": "20130717",
      "center_classification_date": "20130822",
      "termination_date": "20141024",
      "report_date": "20130828",
      "code_info": "Part Number 395067.    All In-date lots (42 lots total).    Lot Number: Manuf. Date: Exp. Date:  M207143 27Jul2012 01/31/2014  M208454 21Sep2012 02/28/2014  M210079 19Oct2012 03/31/2014  M211100 30Nov2012 05/31/2014  M212122 20Dec2012 06/30/2014  M212203 17Jan2013 06/30/2014  M301418  22Feb2013 &  28Feb2013 07/31/2014  M202086 24Feb2012 07/31/2013  M203081 16Mar2012 07/31/2013  M203081A 23Mar2012 07/31/2013  M203262 06Apr2012 08/31/2013  M203098 13Apr2012 08/31/2013  M203098A 20Apr2012 08/31/2013  M203098B 25Apr2012 08/31/2013  M203080 27Apr2012 10/31/2013  M203080A 04May2012 10/31/2013  M203080B 11May2012 10/31/2013  M204276 18May2012 09/30/2013  M205199 12May2012 09/30/2013  M205288 22May2012 11/30/2013  M206021 06June2012 11/30/2013  M206166 18June2012 12/31/2013  M207072 05July2012 12/31/2013  M207143 27July2012 01/31/2014  M206259 26June2012 12/31/2013  M207332 30July2012 01/31/2014  M208345 22Aug2012 01/31/2014  M208272 24Aug2012 02/28/2014  M208454 06Sep2012 02/28/2014  M209135 19Sep2012 03/31/2014  M210079 04Oct2012 03/31/2014  M210169 27Oct2012 04/30/2014  M211100 10Nov2012 05/31/2014  M211078 01Dec2012 05/31/2014  M212122 12Dec2012 06/30/2014  M212203 03Jan2013 06/30/2014  M301324 16Jan2013 07/31/2014  M301418 11Feb2013 07/31/2014  M302410 27Feb2013 08/31/2014  M303157 15Mar2013 09/30/2014  M303223 26Mar2013 09/30/2014  M304130 09Apr2013 09/30/2014"
    }
  ]
}