{
  "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": "2026-09-05",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 6
    }
  },
  "results": [
    {
      "cfres_id": "193357",
      "product_res_number": "Z-1083-2022",
      "event_date_initiated": "2019-10-21",
      "event_date_created": "2022-05-13",
      "recall_status": "Open, Classified",
      "res_event_number": "90087",
      "product_code": "LRG",
      "k_numbers": [
        "K911400"
      ],
      "product_description": "MicroScan WalkAway-40 plus Instrument REF B1018-283",
      "code_info": "Catalog Number: B1018-283\nUDI-DI Code: 1509959065866\nSerial Numbers:\n34010003\n34010004\n34010005\n34010006\n34010007\n34010008\n34010009\n34010010\n34010011\n34010012\n34010013\n34010014\n34010015\n34010016\n34010017\n34010018\n34010019\n34010020\n34010021\n34010022\n34010023\n34010024",
      "firm_fei_number": "2050012",
      "recalling_firm": "Beckman Coulter Inc.",
      "address_1": "250 S Kraemer Blvd",
      "city": "Brea",
      "state": "CA",
      "postal_code": "92821-6232",
      "additional_info_contact": "Jose Untalan\n916-374-3031",
      "reason_for_recall": "WalkAway Instruments may have been assembled with the incorrect AC power entry connector inlet with is rated at 1 ampere current rating rather than the correct current rating of 10 ampere",
      "root_cause_description": "Mixed-up of materials/components",
      "action": "During the week of 10/21/2019, Beckman Coulter sent an \"URGENT MEDICAL DEVICE RECALL\" Letter via e-mail and postal mail informing customers that some WalkAway instruments may have been assembled with the incorrect AC power entry connector inlet with is rated at 1A (ampere) current rating rather than the correct current rating at 10A.\n\nCustomers are instructed to:\nIf the component fails and and the WalkAway suffers a power loss, user should:\n--Contact the Customer Support Center. If in the United States call 1-800-677-7226.  If outside the United States, contact their local Beckman Coulter Representive.\n--Determine if the customer knows how long the WalkAway has been without power.  If the time is unknown or greater than 2 hours, then panels should be reset, or an alternate test method should be used.\n-- If within 2 hours window the instrument will maintain the environmental conditions. Depending on the panel type, the user has the option to read the panels manually, on an autoSCAN-4 (if available) or reset the panels.\n- If the component remains functional, a Beckman Coulter Field Service Representative will contact the user to schedule an onsite visit.  During the visit the representative will inspect the suspect instrument and if the incorrect component is found, will replace the component with the correct one rated at 10A.\n-Complete and return Customer Response Form to Beckman Coulter, Inc.\n1584 Enterprise Blvd.\nWest Sacramento, CA 95691\nAttn: Quality Systems & Compliance\nFax number: 916-374-2119\nEmail address: MicrobiologyCustomersHCUS@beckman.com\n\nFor questions, contact:\n-via website, http://www.beckmancoulter.com/customersupport/support\n-via phone, call 1-800-677-7226 in the United States,\n-If outside the United States, contact the local Beckman Coulter Representative.",
      "product_quantity": "22 systems",
      "distribution_pattern": "Worldwide distribution - U.S. Nationwide distribution in the states of Alaska, Arkansas, California, Colorado, District of Columbia, Florida, Georgia, Idaho, Illinois, Indiana, Iowa, Kentucky, Louisiana, Maine, Maryland, Michigan, Minnesota, Missouri, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Pennsylvania, Tennessee, Texas, Utah, Vermont, Virginia, and Washington. The countries of Belgium, Brazil, Colombia, Germany, Hong Kong, Indonesia, Italy, Japan, Paraguay, Philippines, Poland, Portugal, Romania, Russia, Saudi Arabia, Spain, Switzerland, Taiwan, United Arab Emirates, Vietnam and Yemen.",
      "openfda": {
        "k_number": [
          "K050043",
          "K063065",
          "K063064",
          "K062923",
          "K053243",
          "K896447",
          "K062290",
          "K062276",
          "K062585",
          "K050585",
          "K925859",
          "K103532",
          "K925951",
          "K900821",
          "K063299",
          "K941425",
          "K930478",
          "K061872",
          "K921977",
          "K043545",
          "K911419",
          "K101425",
          "K883907",
          "K981199",
          "K062596",
          "K922482",
          "K063101",
          "K110583",
          "K071316",
          "K063053",
          "K111677",
          "K062293",
          "K062927",
          "K063102",
          "K062375",
          "K063099",
          "K081013",
          "K062179",
          "K041150",
          "K191918",
          "K191914",
          "K865062",
          "K033948",
          "K111205",
          "K911400"
        ],
        "registration_number": [
          "3013718871",
          "1119779",
          "1061932",
          "2919016",
          "3003750284",
          "1530126",
          "8021914",
          "1924669",
          "1950204",
          "3031977134"
        ],
        "fei_number": [
          "3013718871",
          "1119779",
          "3000203293",
          "2919016",
          "1000515493",
          "3003750284",
          "1924669",
          "1950204",
          "3002806332",
          "3031977134"
        ],
        "device_name": "Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems",
        "medical_specialty_description": "Microbiology",
        "regulation_number": "866.1640",
        "device_class": "2"
      }
    }
  ]
}