{
  "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": "Milan",
      "state": "",
      "country": "Italy",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "83516",
      "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": "Nationwide  Foreign:  ARGENTINA  AUSTRALIA  AUSTRIA  AZERBAIJAN  BANGLADESH  BELARUS  BELGIUM  BOSNIA AND HERZEGOVI  BRAZIL  BRUNEI  CANADA  CHILE  COLOMBIA  COSTA RICA  CROATIA  CZECH REPUBLIC  DENMARK  FAROE ISLANDS  FINLAND  FRANCE  GERMANY  GREECE  GREENLAND  HONG KONG  IRELAND  ISRAEL  ITALY  JORDAN  KUWAIT  LEBANON  LUXEMBOURG  MALAYSIA  MALDIVES  MEXICO  MOROCCO  NETHERLANDS  NEW ZEALAND  NIGERIA  NORWAY  OMAN  PAKISTAN  PANAMA  PARAGUAY  PHILIPPINES  POLAND  PORTUGAL  PUERTO RICO  ROMANIA  RWANDA  SAUDI ARABIA  SLOVAKIA  SOUTH AFRICA  SPAIN  ST. VINCENT  SWEDEN  SWITZERLAND  TAIWAN  THAILAND  TURKEY  UAE  UNITED KINGDOM  URUGUAY",
      "recall_number": "Z-2552-2019",
      "product_description": "Alinity c Lithium Reagent Kit- intended for the quantitation of lithium in serum or plasma using respectively the ARCHITECT c Systems and the Alinity c analyzer  List Number: 08P5320",
      "product_quantity": "1217 kits",
      "reason_for_recall": "Added an additional SmartWash parameter for the   Lithium and Alinity c Lithium Reagent Kit, catalogue number 8L25-30 and 08P5320 to prevent the potential for carryover from the ARCHITECT Lactate Dehydrogenase (LDH) reagent (LN 2P56) may result infalsely elevated lithium patient results",
      "recall_initiation_date": "20190628",
      "center_classification_date": "20190920",
      "termination_date": "20200724",
      "report_date": "20191002",
      "code_info": "Lot Number/UDI:  80553Y600/  (01)00380740136277 (17)190731(10)80553Y600;  80444Y600/  (01)00380740136277 (17)190731(10)80444Y600;  80625Y600/  (01)00380740136277 (17)191130(10)80625Y600;  90224Y600/  (01)0038074013627  (17)200229(10)90224Y600",
      "more_code_info": ""
    }
  ]
}