{
  "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": "2026-08-22",
    "results": {
      "skip": 0,
      "limit": 1,
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  "results": [
    {
      "cfres_id": "168810",
      "product_res_number": "Z-0514-2019",
      "event_date_initiated": "2018-10-18",
      "event_date_created": "2018-11-28",
      "recall_status": "Terminated",
      "event_date_terminated": "2020-01-07",
      "res_event_number": "81475",
      "product_code": "GGM",
      "k_numbers": [
        "K964052"
      ],
      "product_description": "HemoTrol Level 2- In Vitro Diagnostic Hematology quality control mixture\nCatalogue number: 171.002.002\n\nEurotrol HemoLin is an assayed hemoglobin control intended for professional use in the verification of the linearity of the HemoCue Hb 201 systems",
      "code_info": "Lot Number: 81166",
      "firm_fei_number": "3005837764",
      "recalling_firm": "EUROTROL INC",
      "address_1": "850 N Black Branch Rd",
      "city": "Elizabethtown",
      "state": "KY",
      "postal_code": "42701",
      "reason_for_recall": "Incorrect measurement results caused by microbial contamination of the product, results in values lower than assigned values",
      "root_cause_description": "Material/Component Contamination",
      "action": "Eurotrol distributors and initial consignees contacted via e-mail with the recall notification letter on 10/16/18. The recall notification letter sent via overnight mail in case e-mail is not deliverable.\n\nThe recall notification letter instructs distributors how to perform the subrecall towards end-users and inform Eurotrol about the performed subrecall actions Primary instruction will be to stop using the product (discard according local regulation on medical waste) and contact Eurotrol for replacement material.\n\nQuestions, contact (Monday through Friday, 9:00 AM to 5:00 PM, Eastern Time):\nName: Eurotrol Inc. Address 850 N Black Branch Rd. Zipcode & city: Elizabethtown, KY 42701 USA Phone: T +1 502 501 1180 E-mail: officeusa@eurotrol.com.",
      "product_quantity": "2000",
      "distribution_pattern": "Worldwide Distribution: US (Nationwide) and countries of: Austria, Australia, Bahrain, France, Hong Kong, Indonesia, Ireland, Japan, Jordan, Kenya, Republic of Korea, Kuwait, Maldives, New Zealand, Mozambique, Pakistan, Poland, Slovenia, Africa, Spain, Thailand, Finland, Norway,  and UK.",
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          "K003030",
          "K052838",
          "K032791",
          "K921681",
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          "K800296",
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          "K192842",
          "K893985",
          "K964052",
          "K070334",
          "K852136",
          "K070546",
          "K993321"
        ],
        "device_name": "Control, Hemoglobin",
        "medical_specialty_description": "Hematology",
        "regulation_number": "864.8625",
        "device_class": "2",
        "registration_number": [
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