{
  "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": "Wiesbaden",
      "state": "N/A",
      "country": "Germany",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "82595",
      "recalling_firm": "Abbott Gmbh & Co. KG",
      "address_1": "Max-Planck-Ring 2",
      "address_2": "65205",
      "postal_code": "N/A",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Worldwide Distribution - US Nationwide to Oklahoma and Texas.      Distributed worldwide to ARGENTINA, AUSTRALIA, AUSTRIA, BELGIUM, BRAZIL, CANADA, CHILE, CHINA, COLOMBIA, CROATIA, CZECH REPUBLIC, FINLAND, FRANCE, GERMANY, GREECE, HONG KONG, INDIA, INDONESIA, ISRAEL, ITALY, JAPAN, MADAGASCAR, MEXICO, NETHERLANDS, NORWAY, PAKISTAN, PHILIPPINES, POLAND, PORTUGAL, ROMANIA, SAUDI ARABIA, SERBIA, SOUTH AFRICA, SOUTH KOREA, SPAIN, SWEDEN, SWITZERLAND, THAILAND, TURKEY, UAE, UNITED KINGDOM, VIETNAM.",
      "recall_number": "Z-1497-2019",
      "product_description": "Alinity i Processing Module, 03R65 01, with the below components.    a. TED (Thermo Electric Device) Engine,  Reagent cooler;      b. CABLE, POWER OUT, TED CNTRLER    Product Usage:  The Alinity i processing module is a fully automated immunoassay analyzer allowing random and continuous access, as well as priority and automated retest processing using chemiluminescent microparticle immunoassay (CMIA) technology. CMIA technology is used to determine the presence of antigens, antibodies, and analytes in samples.",
      "product_quantity": "373 units total",
      "reason_for_recall": "Potential loose cable connections on the reagent cooler, which could result in temperature errors and eventual reagent cooler failure. Could cause burn and shock injuries to users and a delay in test results. Device design has mitigated this risk, but it is a possibility.",
      "recall_initiation_date": "20190405",
      "center_classification_date": "20190530",
      "termination_date": "20220928",
      "report_date": "20190605",
      "code_info": "Part Number: 03R65 01, all Serial Numbers;      a. TED (Thermo Electric Device) Engine,  Reagent cooler - Part Numbers A 30103732 01, A 30103732 02 with all Serial Numbers;      b. CABLE, POWER OUT, TED CNTRLER - Part Numbers A 35006203 01, A 35006203 02 with all Serial Numbers"
    }
  ]
}