{
  "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": "2026-09-05",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "219240",
      "product_res_number": "Z-1806-2026",
      "event_date_initiated": "2026-03-24",
      "event_date_posted": "2026-04-10",
      "recall_status": "Open, Classified",
      "res_event_number": "98616",
      "product_code": "NGZ",
      "k_numbers": [
        "K090968"
      ],
      "product_description": "Yeastone Broth, 11ML, 10/BOX\nYY3462",
      "code_info": "UDI-DI 848838018817\nlots 321046, 329835, 330316, 327069, 330317, 336325, 338314, 341161, 303851, 311723",
      "firm_fei_number": "1924669",
      "recalling_firm": "Remel, Inc",
      "address_1": "12076 Santa Fe Trail Dr",
      "city": "Lenexa",
      "state": "KS",
      "postal_code": "66215-3519",
      "additional_info_contact": "Erica Knox\n800-255-6730",
      "reason_for_recall": "Products may report incorrect AST results during quality control. Health consequences may include delayed response or the need to change to another antifungal agent if laboratory ignores Quality Control test result.",
      "root_cause_description": "Under Investigation by firm",
      "action": "Firm began notifying consignees on March 24, 2026 via letters titled \"Urgent: Medical Device Recall.\"\n\nCustomers were informed that the affected products may report incorrect AST results during quality control.\n\nCustomers were asked to notify any personnel who need to be aware of the issue. Laboratory professionals are advised to review previously reported susceptibility results generated using affected lots and assess whether retesting is appropriate. Remaining inventory of affected lots must be destroyed; these lots should not be used for any clinical laboratory testing.\n\nThe firm is investigating the root cause and will implement corrective and preventive actions to prevent future recurrence.",
      "product_quantity": "2819",
      "distribution_pattern": "Worldwide distribution - US Nationwide and the countries of Canada, Vietnam, France, Argentina, Qatar, New Zealand, Uruguay, Turkey, Netherlands, Singapore.",
      "openfda": {
        "k_number": [
          "K090968",
          "K221198",
          "K092454",
          "K081063",
          "K040560",
          "K061945",
          "K151817",
          "K232963",
          "K231433",
          "K211539",
          "K232967",
          "K991810",
          "K133038",
          "K181368",
          "K133817",
          "K101566",
          "K151923",
          "K221899",
          "K133952",
          "K082534",
          "K243738"
        ],
        "device_name": "Susceptibility Test Plate, Antifungal",
        "medical_specialty_description": "Microbiology",
        "regulation_number": "866.1640",
        "device_class": "2",
        "registration_number": [
          "3013718871",
          "3003750284",
          "1530126",
          "8021914",
          "9615754",
          "1924669",
          "1950204",
          "3031977134"
        ],
        "fei_number": [
          "3013718871",
          "1000515493",
          "3003750284",
          "3008237827",
          "1924669",
          "1950204",
          "3002806332",
          "3031977134"
        ]
      }
    }
  ]
}