{
  "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": "219076",
      "product_res_number": "Z-1609-2026",
      "event_date_initiated": "2025-07-24",
      "event_date_posted": "2026-03-20",
      "recall_status": "Open, Classified",
      "res_event_number": "98555",
      "product_code": "LTT",
      "k_numbers": [
        "K202343"
      ],
      "product_description": "MicroScan Neg MIC 56 REF C42464\nUDI-DI code: 15099590731212\n\nMicroScan panels are designed for use in determining antimicrobial agent susceptibility and/or identification to the species level of aerobic and facultatively anaerobic gram-negative bacilli.",
      "code_info": "Catalog Number: C42464\nUDI-DI code: 15099590731212\nLot Number: 2026-01-03",
      "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": "530-990-4396",
      "reason_for_recall": "Due to the likely presence of contamination in well(s).",
      "root_cause_description": "Material/Component Contamination",
      "action": "On 07/24/2025, the firm sent via mail/email an \"URGENT MEDICAL DEVICE RECALL\" Letter to customers informing them that Beckman Coulter has received reports that when testing clinical isolates there was no growth observed in Ceftazidime (Caz) 1, 8 and 16 mg/mL wells; however, growth was observed in the 4 mg/mL well with multiple panels from this lot.  Upon further investigation, it was confirmed the growth was Bacillus spp. and not the clinical isolates being tested.\n\nCustomers are instructed to:\n-Consider reviewing previous Caz antimicrobial test results from this lot for any spot growth detection (e.g., isolates with no growth in in Caz 1, 8 and 16 mg/mL wells and growth in the 4 mg/mL well or if there is an unusual increase in Caz MIC values).\n-Discontinue use of MicroScan Neg MIC 56 Lot 2026-01-03\n\nFor any questions regarding this notice, contact Customer Technical Support:\n-From our website: http://www.beckmancoulter.com\n-By phone: call 800 677-7226 option 1 in the United States.\n\nIf replacement product is needed:\n-Complete the attached  Replacement Order Form  and email to askbeckman@beckman.com or fax to (866) 294-7850 OR\n-Call Client Services at (800) 526-3821",
      "product_quantity": "685 boxes",
      "distribution_pattern": "U.S. Nationwide distribution in the states of CA, CO, IN, MA, MD, MN, MO, NC, NJ, OK, PA, and TX.",
      "openfda": {
        "k_number": [
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          "K123933",
          "K150039",
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          "K243804",
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          "K030620",
          "K020627",
          "K111394",
          "K033940",
          "K010508",
          "K960366",
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          "K083262",
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          "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"
      }
    }
  ]
}