{
  "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": "2026-08-20",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "210333",
      "product_res_number": "Z-0266-2025",
      "event_date_initiated": "2024-09-20",
      "event_date_posted": "2024-10-30",
      "recall_status": "Open, Classified",
      "res_event_number": "95458",
      "product_code": "JFO",
      "k_numbers": [
        "K920974"
      ],
      "product_description": "remel BactiDrop Acridine Orange, REF 21502, 50 per package.",
      "code_info": "Lot 733100, Exp. 2025-04-04; UDI-DI 848838000447.",
      "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": "A color change of the solution within the dropper can occur from orange-yellow to light yellow resulting in out-of-specification fluorescent stain results.",
      "root_cause_description": "Under Investigation by firm",
      "action": "The recalling firm issued letters dated 9/18/2024 on 9/20/2024 via first class mail.  The letter explained the reason for recall, risk to health, product distribution information, and actions to be taken by the consignee, which included destroying any remaining inventory of the affected lot number and completion and return of the Acknowledgement Form indicating the number of units destroyed.  The form was to be returned via email.  The notice was to be passed onto all who need to be aware within the consignee's organization or to any organization where the affected products  have been transferred.",
      "product_quantity": "29 kits",
      "distribution_pattern": "Distribution was made to IL, IN, MN, NE, SD, TX, VA, and WA.  There was government distribution but no military distribution.\n\nForeign distribution was made to the United Kingdom.",
      "openfda": {
        "registration_number": [
          "1924669",
          "2431530",
          "3037000637",
          "3006198300"
        ],
        "fei_number": [
          "1924669",
          "2431530",
          "3037000637",
          "3006198300"
        ],
        "device_name": "Fluorometric, Calcium",
        "medical_specialty_description": "Clinical Chemistry",
        "regulation_number": "862.1145",
        "device_class": "2",
        "k_number": [
          "K920974"
        ]
      }
    }
  ]
}