{
  "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": "142201",
      "product_res_number": "Z-0561-2016",
      "event_date_initiated": "2015-12-01",
      "event_date_created": "2015-12-30",
      "recall_status": "Terminated",
      "event_date_terminated": "2016-07-29",
      "res_event_number": "72779",
      "product_code": "LTT",
      "product_description": "MicroScan Pos Breakpoint Combo Panel Type 20, Part No. B1017-202\n\nMicroScan Pos (Positive) panels are designed for use in determining antimicrobial agent susceptibility and/or identification to the species level of rapidly growing aerobic and facultative gram-positive cocci, some fastidious aerobic gram-positive cocci and Listeria monocytogenes.",
      "code_info": "2016-04-30 Part No. B1017-202",
      "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": "Rula Melconian\n714-961-4295",
      "reason_for_recall": "Beckman Coulter has confirmed falsely negative results for Voges-Proskauer (VP) (pale-pink/brown/colorless) with Quality Control (QC) American Type Culture Collection (ATCC) organism Staphylococcus aureus ATCC 29213 in a portion of affected lots of MicroScan Pos Combo and MicroScan Pos Breakpoint Combo panels. The expected result is positive.",
      "root_cause_description": "Device Design",
      "action": "The firm, Beckman Coulter, sent an \"URGENT MEDICAL DEVICE RECALL\" letter dated December 1, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The customers were instructed to discontinue use and discard any remaining inventory of lots listed; return the attached form for product replacement; retain your inventory of the other lot numbers of the panel types, as they are not impacted by this issue; discuss content of the letter with your laboratory director/staff, retain the notification as part of your laboratory QS documentation; if you have forwarded any of the affected products to another laboratory provide them a copy of the letter, and complete and return the enclosed Response Form within 10 days via mail to: Beckman Coulter, Inc., 1584 Enterprise Blvd., West Sacramento, CA 95691, Attn: Quality Systems & Compliance or Fax: 916-374-2119 or email: MicrobiologyCustomersHCUS@beckman.com.\n\nCustomers with questions are instructed to contact their Customer Support Representative at http://www.beckmancoulter.com or by phone at (800) 677-7226 in US and Canada.",
      "product_quantity": "751 units total (701 units in US)",
      "distribution_pattern": "Worldwide Distribution - USA (nationwide) Distribution and to the countries of :  Austria, Belgium, Brazil, Canada, Germany, Italy, Japan, Kazakhstan, Kuwait, Mexico, Myanmar, Netherlands, Norway, Panama, Poland, Portugal, Romania, Russian Federation, Spain, Taiwan, Thailand and United Kingdom.",
      "openfda": {
        "k_number": [
          "K123933",
          "K162740",
          "K962150",
          "K011116",
          "K010159",
          "K010418",
          "K003619",
          "K021111",
          "K024353",
          "K172337",
          "K250084",
          "K020627",
          "K172255",
          "K972799",
          "K083262",
          "K020626",
          "K172912",
          "K111394",
          "K150039",
          "K033940",
          "K062777",
          "K202343",
          "K960366",
          "K945235",
          "K021078",
          "K030620",
          "K010508",
          "K062773",
          "K243804",
          "K250036",
          "K091949",
          "K001721",
          "K131275",
          "K183127",
          "K935704",
          "K091264",
          "K941030",
          "K013195",
          "K021184",
          "K020939",
          "K024357",
          "K193358",
          "K993102",
          "K020160",
          "K193536",
          "K983309",
          "K201423",
          "K013368",
          "K983306",
          "K973317"
        ],
        "pma_number": [
          "N62160",
          "N50494"
        ],
        "registration_number": [
          "3013661582",
          "3009171251",
          "3012389632",
          "1530126",
          "3003750284",
          "3009637528",
          "1119779",
          "8021914",
          "1950204",
          "3013718871",
          "1924669",
          "2919016",
          "3031977134"
        ],
        "fei_number": [
          "3013661582",
          "3012389632",
          "3003750284",
          "3009637528",
          "1119779",
          "3006759904",
          "1000515493",
          "1950204",
          "3013718871",
          "1924669",
          "3002806332",
          "2919016",
          "3031977134"
        ],
        "device_name": "Panels, Test, Susceptibility, Antimicrobial",
        "medical_specialty_description": "Microbiology",
        "regulation_number": "866.1640",
        "device_class": "2"
      }
    }
  ]
}