{
  "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": "2026-07-08",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Wiesbaden",
      "state": "",
      "country": "Germany",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "94205",
      "recalling_firm": "Abbott GmbH",
      "address_1": "Max-Planck-Ring 2",
      "address_2": "",
      "postal_code": "N/A",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "US Nationwide distribution.",
      "recall_number": "Z-1479-2024",
      "product_description": "ARCHITECT Anti-HCV Reagent Kit, List Numbers:  a) 1L79-25, b) 1L79-35",
      "product_quantity": "7219 units",
      "reason_for_recall": "Customer complaints were received regarding falsely elevated results for some patient samples. Internal studies with customer return samples confirmed potential interactions that may lead to falsely elevated results when processed as below on the same instrument:  \" ARCHITECT Syphilis TP (LN 8D06) and/or ARCHITECT AdviseDx SARS-CoV-2-IgG II (LN 6S60) precedes ARCHITECT Anti-HCV testing (LN 1L79).  \" Alinity i Syphilis TP (LN 07P60) precedes Alinity i Anti-HCV testing (LN 08P05).",
      "recall_initiation_date": "20240304",
      "center_classification_date": "20240404",
      "report_date": "20240410",
      "code_info": "a) 1L79-25, 00380740001414, Lot Numbers:  52011BE00, 54140BE00, 56375BE00, 58163BE00, 59194BE00;  b) 1L79-35, 00380740001421, Lot Numbers:  52015BE00, 54144BE00, 56379BE00, 58167BE00, 59198BE00",
      "more_code_info": ""
    }
  ]
}