{
  "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": "2026-04-15",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Milan",
      "state": "N/A",
      "country": "Italy",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "77405",
      "recalling_firm": "Sentinel CH SPA",
      "address_1": "Via Robert Koch 2",
      "address_2": "N/A",
      "postal_code": "N/A",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide Distribution",
      "recall_number": "Z-2867-2017",
      "product_description": "MULTIGENT Creatinine (Enzymatic), Catalog Numbers 8L24-31 and 8L24-41; IVD.  Intended for the quantitative determination of creatinine in human serum, plasma, and urine using the ARCHITECT c Systems  The product is a medical device (chemistry reagent) and is intended for the quantitative determination of creatinine in human serum, plasma, and urine using the ARCHITECT c Systems. The kit is provided as a ready to use liquid material consisting in two components: Reagent 1 and Reagent 2. According to the catalogue number, the kit is composed of three vials of 48 ml for Reagent 1 and three vials of 18 ml for Reagent 2 in the configuration 8L24-31. The configuration 8L24-41 consists in ten vials of 90 ml for Reagent 1 and ten vials of 34 ml for Reagent 2",
      "product_quantity": "2356 kits Worldwide; US  206 kits",
      "reason_for_recall": "Reagent 1 component may result in Quality Control values shifting out of acceptable range, which is not resolved by recalibration.",
      "recall_initiation_date": "20170522",
      "center_classification_date": "20170803",
      "termination_date": "20180904",
      "report_date": "20170809",
      "code_info": "Catalog Number 8L24-31: Lot Numbers: 60335Y600, 60382Y600 (Exp. Date 2018-02-28);  Catalog Number 8L24-41: Lot Number: 60334Y600, (Exp. Date 2018-02-28)"
    }
  ]
}