{
  "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": "192646",
      "product_res_number": "Z-0905-2022",
      "event_date_initiated": "2022-03-16",
      "event_date_created": "2022-04-11",
      "recall_status": "Terminated",
      "event_date_terminated": "2025-01-02",
      "res_event_number": "89829",
      "product_code": "QEI",
      "product_description": "Separation Technology Creamatocrit Plus, Catalog Number: 100-146",
      "code_info": "Sold between 2019 and 2021",
      "firm_fei_number": "1616487",
      "recalling_firm": "Stanbio Laboratory, LP",
      "address_1": "1261 N Main St",
      "city": "Boerne",
      "state": "TX",
      "postal_code": "78006-3014",
      "additional_info_contact": "830-249-0772",
      "reason_for_recall": "The device was being marketed as an IVD without a 510(k). Therefore, performance characteristics of these breast milk analyzers have not been adequately validated.  An erroneous result could lead to sub-optimal nutrition supplementation for patients (infants)",
      "root_cause_description": "No Marketing Application",
      "action": "On 03/16/22, recall notices were mailed to customers who were asked to take the following actions:\n\nStop using the affected device while you review the new Research Use Only labeling included with this letter. If you are using the affected device for research use only, then apply/use the new labeling. If you are using the affected human breast milk analyzer to provide information relating to the nutritional management of infants, then destroy the product in accordance with local regulations.\n\nIf the affected product was further distributed or forwarded elsewhere, then forward this recall notice to all that need to be aware; alternately, provide a customer contact list so the recalling firm can send this recall notice to these customers.\n\nPlease complete the Recall Return Response form to the recalling firm.  Customers with additional questions are asked to contact Technical Support, Monday through Friday, 8:00 AM to 5:00 PM, Central Time at 1-800-531-5535 or via email at productsafety@ekfdiagnostics.com.",
      "product_quantity": "50",
      "distribution_pattern": "US Nationwide Distribution CA, TX, OK, SD, IL, NV, MO, FL, WA, KY, WI, PA, NC, GA, MD, MN",
      "openfda": {
        "k_number": [
          "K234088",
          "K223085",
          "DEN180007"
        ],
        "registration_number": [
          "3013887826"
        ],
        "fei_number": [
          "3013887826"
        ],
        "device_name": "Breast Milk Macronutrients Test System",
        "medical_specialty_description": "Clinical Chemistry",
        "regulation_number": "862.1493",
        "device_class": "2"
      }
    }
  ]
}