{
  "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": "2026-08-15",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "140096",
      "product_res_number": "Z-0108-2016",
      "event_date_initiated": "2015-09-10",
      "event_date_posted": "2015-10-07",
      "recall_status": "Terminated",
      "event_date_terminated": "2016-01-22",
      "res_event_number": "72176",
      "product_code": "LTT",
      "k_numbers": [
        "K020626",
        "K062773",
        "K062927",
        "K091949"
      ],
      "product_description": "MICroSTREP plus 1 Panel, Part No. B1027-201\n\nProduct Usage:\nMicroScan MICroSTREP plus panels are designed for use in determining quantitative and/or qualitative antimicrobial agent susceptibility of colonies grown on solid media of aerobic streptococci, including Streptococcus pneumoniae.",
      "code_info": "2016-01-27  2016-02-27  2016-03-26  2016-04-02  2016-04-14  2016-05-01  2016-05-15  2016-06-12",
      "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 is recalling MICroSTREP plus 1 and MICroSTREP plus 2 panels because a manufacturing error may lead to antimicrobic degradation and the potential for elevated or false resistant results.",
      "root_cause_description": "Equipment maintenance",
      "action": "Beckman Coulter Inc. sent an Urgent Medical Device Recall letter dated Setember 10, 2015  to all customers who purchased the MICroSTREP plus 1 and MICroSTREP plus 2.  The letter identified the affected products, problem and the actions to be taken.  Customers are instructed to complete and return the enclosed Response Form within 10 days.  Customers with questions regarding the notice, are instructed to contact their  Customer Support Representative:website: http://www.beckmancoulter.com or by phone: 1-800-677-7226 in the United States and Canada.",
      "product_quantity": "5138 units total (4,360 units in US)",
      "distribution_pattern": "Worldwide Distribution - US Nationwide and the countries of  Bahamas, Belgium, Canada, Ecuador, Germany, Italy, Republic of Korea, Mexico, Peru, Poland, Romania, Saudi Arabia, South Africa, Thailand, United Sates (including Puerto Rico), and Uruguay.",
      "openfda": {
        "k_number": [
          "K193536",
          "K033940",
          "K062777",
          "K172255",
          "K193358",
          "K972799",
          "K172912",
          "K962150",
          "K250036",
          "K945235",
          "K123933",
          "K020939",
          "K024353",
          "K983306",
          "K003619",
          "K062773",
          "K131275",
          "K030620",
          "K250084",
          "K010159",
          "K162740",
          "K021078",
          "K013368",
          "K201423",
          "K935704",
          "K941030",
          "K010508",
          "K011116",
          "K013195",
          "K960366",
          "K183127",
          "K083262",
          "K010418",
          "K243804",
          "K021111",
          "K983309",
          "K020626",
          "K202343",
          "K172337",
          "K001721",
          "K993102",
          "K973317",
          "K111394",
          "K020627",
          "K024357",
          "K020160",
          "K091949",
          "K091264",
          "K021184",
          "K150039"
        ],
        "pma_number": [
          "N62160",
          "N50494"
        ],
        "registration_number": [
          "8021914",
          "1950204",
          "1530126",
          "1924669",
          "3013718871",
          "3009637528",
          "3012389632",
          "3013661582",
          "3009171251",
          "1119779",
          "2919016",
          "3003750284",
          "3031977134"
        ],
        "fei_number": [
          "1950204",
          "1924669",
          "1000515493",
          "3013718871",
          "3009637528",
          "3012389632",
          "3013661582",
          "1119779",
          "3003750284",
          "2919016",
          "3006759904",
          "3031977134",
          "3002806332"
        ],
        "device_name": "Panels, Test, Susceptibility, Antimicrobial",
        "medical_specialty_description": "Microbiology",
        "regulation_number": "866.1640",
        "device_class": "2"
      }
    }
  ]
}