{
  "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": "Wiesbaden",
      "state": "N/A",
      "country": "Germany",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "81916",
      "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",
      "recall_number": "Z-0789-2019",
      "product_description": "Alinity i Processing Module,   (a) Part Number 03R65-01  (b) Part Number A-30108552-01  (c) Part Number A-30109694-01      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": "434 units",
      "reason_for_recall": "Abbott has identified an issue with the Alinity i Gear Pump Assembly (part number A 30108552 01) resulting in foaming/bubbling out of the bottle reservoir for Concentrated Wash Buffer and an unexpected amount of dried residue of buffer.  The foaming/bubbling is a result of an improper calibration of the pump s operating speed.",
      "recall_initiation_date": "20181220",
      "center_classification_date": "20190130",
      "termination_date": "20220919",
      "report_date": "20190206",
      "code_info": "(a) Serial Numbers:  Ai01001 - Ai01455, Ai01457, Ai01459  (b) all Serial Numbers  (c) all Serial Numbers"
    }
  ]
}