{
  "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": "2026-09-17",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "219075",
      "product_res_number": "Z-1772-2026",
      "event_date_initiated": "2025-06-25",
      "event_date_posted": "2026-04-03",
      "recall_status": "Open, Classified",
      "res_event_number": "98553",
      "product_code": "LTT",
      "product_description": "MicroScan Neg MIC 3J REF C54814",
      "code_info": "Catalog Number: C54814\nUDI code: N/A\nLot Number: 2025-08-23",
      "firm_fei_number": "2919016",
      "recalling_firm": "Beckman Coulter, Inc.",
      "address_1": "2040 Enterprise Blvd",
      "city": "West Sacramento",
      "state": "CA",
      "postal_code": "95691-3427",
      "additional_info_contact": "Kurtis Montegna\n530-990-3496",
      "reason_for_recall": "Due to a manufacturing issue - missing a drug in well 4/4 but contain double the amount of antibiotics",
      "root_cause_description": "Process control",
      "action": "On 07/15/2024, firm sent via mail/email an \"URGENT MEDICAL DEVICE RECALL\" Letter to customer inform them that customers have reported multiple patient samples with skipped wells for Ceftolozane/Tazobactam (C/T) when tested with MicroScan Neg MIC 3J Lot 2025-08-23. The C/T 2/4 dilution well exhibited no growth while growth was observed in the C/T 4/4 well.\n\nCustomers are instructed to:\n\"Discontinue use of this lot and discard per your laboratory guidelines.\n\"Consider reviewing the C/T antimicrobial susceptibility test results from this lot if Enterobacterales reported as resistant and P. aeruginosa reported as intermediate or if an increasing trend in resistance has been observed for C/T in your laboratory.\n\"The laboratory should retain the inventory of other MicroScan Neg MIC 3J lots as they are not impacted by this issue.\n\nany questions regarding this notice, please contact us:\n\"From our website: http://www.beckmancoulter.com\n\"By phone: please contact: Customer call center TEL :0120-566-730",
      "product_quantity": "688 boxes (20 panels per box)",
      "distribution_pattern": "International distribution in the country of Japan.",
      "openfda": {
        "k_number": [
          "K172912",
          "K123933",
          "K150039",
          "K172255",
          "K243804",
          "K250084",
          "K030620",
          "K020627",
          "K111394",
          "K033940",
          "K010508",
          "K960366",
          "K941030",
          "K001721",
          "K193358",
          "K945235",
          "K024357",
          "K983309",
          "K083262",
          "K013368",
          "K162740",
          "K003619",
          "K172337",
          "K021184",
          "K062777",
          "K011116",
          "K193536",
          "K020626",
          "K972799",
          "K935704",
          "K962150",
          "K201423",
          "K091264",
          "K983306",
          "K010159",
          "K024353",
          "K062773",
          "K021078",
          "K020160",
          "K250036",
          "K973317",
          "K131275",
          "K020939",
          "K183127",
          "K021111",
          "K010418",
          "K091949",
          "K013195",
          "K202343",
          "K993102"
        ],
        "pma_number": [
          "N62160",
          "N50494"
        ],
        "registration_number": [
          "3012389632",
          "8021914",
          "1530126",
          "1119779",
          "3031977134",
          "1924669",
          "2919016",
          "3009637528",
          "1950204",
          "3003750284",
          "3013661582",
          "3009171251",
          "3013718871"
        ],
        "fei_number": [
          "3012389632",
          "1119779",
          "3002806332",
          "3031977134",
          "1924669",
          "2919016",
          "3009637528",
          "3006759904",
          "1950204",
          "3003750284",
          "3013661582",
          "3013718871",
          "1000515493"
        ],
        "device_name": "Panels, Test, Susceptibility, Antimicrobial",
        "medical_specialty_description": "Microbiology",
        "regulation_number": "866.1640",
        "device_class": "2"
      }
    }
  ]
}