{
  "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": "Ongoing",
      "city": "Wiesbaden",
      "state": "N/A",
      "country": "Germany",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "85590",
      "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 distribution including in the states of AL, AZ, CA, CT, DE, FL, HI, IA, ID, IL, IN, KS, KY, LA, MA, ME, MI, MN, MO, MT, ND, NE, NJ, NV, NY, OH, OK, PA, RI, SC, TN,TX, UT, VA, VT,  WA, WI, PR.    The countries of Algeria, Argentina, Australia, Austria, Bahrain, Barbados, Belarus, Belgium, Brazil, Brunei, Canada, Cayman Islands, Chile, China, Costa Rica, Croatia, Curacao, Czech Republic, Faroe Islands, France, Germany, Greece, Greenland, Hong Kong, Hungary, Ireland, Israel, Italy, Japan, Jordan, Kenya, Latvia, Lebanon, Lithuania, Malaysia, Mauritius, Namibia, Netherlands, New Zealand, Norway, Oman, Palestinian Territory, Philippines, Poland, Portugal, Republic of Yemen, Saudi Arabia, Slovakia, Slovenia, South Africa, South Korea, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Tunisia, UAE, United Kingdom and Uruguay.",
      "recall_number": "Z-2117-2020",
      "product_description": "ARCHITECT iGentamicin Reagent Kit - Product Usage: The measurements obtained are used in the diagnosis and treatment of gentamicin overdose and in monitoring levels of gentamicin to help ensure appropriate therapy.",
      "product_quantity": "6087 Reagent Kits",
      "reason_for_recall": "Abbott identified that samples tested for ARCHITECT STAT High Sensitive Troponin I and  STAT High Sensitivity Troponin I assays (LN 3P25 and LN 2R98) may show interaction when  processed directly after the ARCHITECT iGentamicin (LN 1P31) assay and patient results might be impacted.",
      "recall_initiation_date": "20200424",
      "center_classification_date": "20200526",
      "report_date": "20200603",
      "code_info": "MODEL: 1P31-25  LOT NUMBERS: 04281BE00, 08510BE00 and 11221BE00  Shelf life per LOT:  04281BE00;2020-MAY-21  08510BE00; 2020-AUG-08  11221BE00;2020-NOV-18"
    }
  ]
}