{
  "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,
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    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Milan",
      "state": "",
      "country": "Italy",
      "classification": "Class III",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "88040",
      "recalling_firm": "Sentinel CH SpA",
      "address_1": "Via Robert Koch 2",
      "address_2": "",
      "postal_code": "N/A",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "E-Mail",
      "distribution_pattern": "Worldwide distribution - US Nationwide and the countries of AUSTRALIA, AUSTRIA, BANGLADESH, BELGIUM, CANADA, CROATIA, CZECH REPUBLIC, DENMARK, EGYPT, FINLAND, FRANCE, GERMANY, GREECE, IRELAND, ISRAEL, ITALY, JORDAN, NEW ZEALAND, POLAND, PORTUGAL, SERBIA, SOUTH AFRICA, SPAIN, SWEDEN, THE NETHERLANDS, TURKEY, U.A.E., UK.",
      "recall_number": "Z-2012-2021",
      "product_description": "ACE Control Set - IVD Control set for the quantitative determination of Angiotensin Converting Enzyme (ACE)    REF 1667001",
      "product_quantity": "1898 kits",
      "reason_for_recall": "Claim for stability after reconstitution from lyophilized to liquid form does not meet the requirements.    New IFU instructions for handling the product provided to end users.",
      "recall_initiation_date": "20210430",
      "center_classification_date": "20210706",
      "report_date": "20210714",
      "code_info": "Lot Numbers/ Exp. Date:  80516  31/07/2021;  80635  30/09/2021;  90092  31/12/2021;  90599  31/12/2021;  00118  31/12/2021;  00360  31/12/2021;  00610  31/12/2021;  00702  31/12/2021.    UDI:  01)08058056681775( 17)210731( 10)80516(240) 1667001  {01)08058056681775( 17)210930(10)80635{240) 1667001  {01)08058056681775( 17)211231(10)90092(240) 1667001  {01)08058056681775( 17)211231(10)90599{240) 1667001  {01)08058056681775( 17)211231( 10)00118(240) 1667001  {01)08058056681775( 17)211231(10)00360(240) 1667001  {01)08058056681775( 17)211231( 10)00610(240) 1667001  {01)08058056681775( 17)211231(10)00702{240) 1667001",
      "more_code_info": ""
    }
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}