{
  "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": "104677",
      "product_res_number": "Z-0191-2012",
      "event_date_initiated": "2011-09-21",
      "event_date_posted": "2011-11-16",
      "recall_status": "Terminated",
      "event_date_terminated": "2013-02-01",
      "res_event_number": "60174",
      "product_code": "LKN",
      "k_numbers": [
        "K071079",
        "K103090"
      ],
      "product_description": "Spectra Optia Apheresis System, REF: 61000, Caridian BCT, Lakewood, CO 80215.\n\nA blood component separator used for therapeutic plasma exchanges.",
      "code_info": "Serial Numbers: 1P00100 - 1P00XXX",
      "firm_fei_number": "1000117351",
      "recalling_firm": "Caridian BCT, Incorporated",
      "address_1": "10811 W Collins Ave",
      "city": "Lakewood",
      "state": "CO",
      "postal_code": "80215-4440",
      "additional_info_contact": "303-239-2241",
      "reason_for_recall": "Possible higher than expected platelet loss following therapeutic plasma exchange or plasmapheresis.",
      "root_cause_description": "Software design",
      "action": "CaridianBCT sent a \"Safety Alert\" letter dated September 2011, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. \n\nThe firm will be sending a recall letter to consignees in November 2011,  stating they are voluntarily recalling the software and will provide an upgrade once the software has been approved.\n\nIf you have any further questions please contact your CaridianBCT Representative, the CaridianBCT Support Center at 1-877-3-FYU-BCT  \n( US Toll free 1-877-299-4228 )  or (303) 231-HELP )  ( 1  (303) 231-4357, or your local CaridianBCT Customer Service office.",
      "product_quantity": "852 units (US: 333; Foreign: 519)",
      "distribution_pattern": "Worldwide Distribution -- USA ( nationwide )  and the countries of  Australia, Belgium, Canada, Chile, China, Colombia, Hong Kong, India, Japan, Malaysia, Mexico, Pakistan, Republic of Korea, Saudi Arabia, Singapore, South Africa, Taiwan, Thailand and Vietnam.",
      "openfda": {
        "k_number": [
          "K895435",
          "K172590",
          "K900105",
          "K141019",
          "K926409",
          "K113480",
          "K111702",
          "K103090",
          "K850621",
          "K071079",
          "K132429",
          "K830831",
          "K151368",
          "K961706",
          "K953681",
          "K060734",
          "K153601",
          "K141938",
          "K050273",
          "K874607",
          "K893962",
          "K831004",
          "K181049",
          "K192150",
          "K131744",
          "K183081",
          "K180615"
        ],
        "pma_number": [
          "P810023",
          "P850092",
          "P820002",
          "P830010",
          "P820032",
          "P850020"
        ],
        "registration_number": [
          "9612051",
          "3003464075",
          "2029015",
          "3019807891",
          "1722028",
          "1721686",
          "9680001",
          "1720929",
          "3004548776",
          "2032098",
          "1643817",
          "2032112",
          "1219343",
          "3004634229",
          "3005778453",
          "3020981987",
          "9616074",
          "3010273872",
          "1450662",
          "9617787"
        ],
        "fei_number": [
          "1000160458",
          "3003464075",
          "3003076831",
          "3019807891",
          "1721686",
          "1720929",
          "3004548776",
          "1000117351",
          "1643817",
          "3002654698",
          "1219343",
          "3004634229",
          "3005778453",
          "3020981987",
          "3002806457",
          "3010273872",
          "3002808445",
          "3003327833",
          "1450662",
          "3003058448"
        ],
        "device_name": "Separator, Automated, Blood Cell And Plasma, Therapeutic",
        "medical_specialty_description": "Unknown",
        "regulation_number": "",
        "device_class": "U"
      }
    }
  ]
}