{
  "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": "2026-04-01",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Bronshoj",
      "state": "N/A",
      "country": "Denmark",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "85390",
      "recalling_firm": "Radiometer Medical ApS",
      "address_1": "Akandevej 21",
      "address_2": "N/A",
      "postal_code": "N/A",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit",
      "distribution_pattern": "Worldwide distribution - US Nationwide. Also distributed OUS.",
      "recall_number": "Z-2139-2020",
      "product_description": "ABL90 FLEX, model no. 393-090; and Spare Part Hemolyzer Units (902-980): R0526 - R0941  - Product Usage: are intended for use by trained technologists, nurses, physicians and therapists. It is intended for use in a laboratory environment, near patient or point-of-care setting.",
      "product_quantity": "1233 units",
      "reason_for_recall": "The analyzers fail on S7950 (Range +) QC measurements due to the hemolyzer cuvettes, a subcomponent of the optical system which measures ctHb and derivates. In a cuvette with light shunt, some of the received light has not been transmitted through the sample. This will lead to a perturbed and non-linear absorbance spectrum which results in measurement errors.",
      "recall_initiation_date": "20191121",
      "center_classification_date": "20200528",
      "termination_date": "20241108",
      "report_date": "20200603",
      "code_info": "ABL90 FLEX Model no. 393-090: R0659 - R0977 and Spare Part Hemolyzer Units (902-980): R0526 - R0941"
    }
  ]
}