{
  "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": "219085",
      "product_res_number": "Z-1794-2026",
      "event_date_initiated": "2025-09-08",
      "event_date_posted": "2026-04-08",
      "recall_status": "Open, Classified",
      "res_event_number": "98562",
      "product_code": "LTT",
      "product_description": "MicroScan Neg Multidrug Resistant MIC 1 REF C32368\nUDI-DI code: 15099590720568\n\nIntended Use- For use with MicroScan Dried Gram Negative\nMIC/Combo Panels and Dried Gram Negative Breakpoint Combo\nPanels. MicroScan panels are designed for use in determining\nantimicrobial agent susceptibility and/or identification to the species level\nof aerobic and facultatively anaerobic gram-negative bacilli.",
      "code_info": "Catalog Number: C32368\nUDI-DI code: 15099590720568\nLot Number: 2026-05-08",
      "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 manufacturing issue (incorrectly processing) with in vitro multidrug resistant test.",
      "root_cause_description": "Under Investigation by firm",
      "action": "On 09/08/2025, the firm sent via mail/email an \"URGENT FIELD SAFETY NOTICE\" to customers informing them that as a result of an internal investigation Beckman Coulter confirmed that Ciprofloxacin (Cp) antimicrobial agent was incorrectly manufactured on MicroScan Neg Multidrug Resistant MIC 1 Lot 2026-05-08.\n\nCustomers are instructed to:\n\"Review Ciprofloxacin results generated from Lot 2026-05-08 to identify any abnormal or unexpected trends in both susceptible and resistance patterns, or unexpected change in MIC trends, as compared to historical results for that same species (e.g. a sudden, unexplained increase in susceptible or % susceptible results for a species after implementation of Lot 2026-05-08 versus the previous susceptible or % susceptible results for the same species prior to using Lot 2026-05-08).\n\"Discontinue use of this lot and discard per your laboratory guidelines\n\"The laboratory should retain the inventory of other MicroScan Neg Multidrug Resistant MIC 1 lots as they are not impacted by this issue.\n\nNote-Beckman Coulter is no longer distributing MicroScan Neg Multidrug Resistant MIC 1 Lot 2026-05-08\n\nFor questions - contact Customer Support Center from website: http://www.beckmancoulter.com",
      "product_quantity": "3 boxes",
      "distribution_pattern": "International distribution to the country of Poland.",
      "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"
      }
    }
  ]
}