{
  "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": "2026-10-28",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Ballina Tipperary",
      "state": "",
      "country": "Ireland",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "99724",
      "recalling_firm": "TECHNO-PATH MANUFACTURING LTD.",
      "address_1": "Fort Henry Business Park",
      "address_2": "",
      "postal_code": "N/A",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "E-Mail",
      "distribution_pattern": "US Nationwide distribution in the state of Massachusetts.",
      "recall_number": "Z-0205-2027",
      "product_description": "Techno-Path  Multichem AE Unassayed Level 1  REF:AE621X",
      "product_quantity": "832 units",
      "reason_for_recall": "A routine stability studies have identified a stability drift affecting the Ammonia (NH4+) analyte in specific lots of Multichem AE quality control material. Additional testing confirmed that the labelled shelf-life performance claim for the Ammonia analyte can no longer be supported for the affected lots. This issue is limited to the Ammonia analyte only.     The impacted device may cause delay of issuing results to the physician. Delayed recognition and diagnosis of elevated levels may impact in timely treatment of life-threatening levels described within medical toxicity intervention decision points.",
      "recall_initiation_date": "20260814",
      "center_classification_date": "20261022",
      "report_date": "20261028",
      "code_info": "UDI: (01)05391523442800/Lot # 65705261",
      "more_code_info": ""
    }
  ]
}