{
  "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": "2026-09-10",
    "results": {
      "skip": 0,
      "limit": 1,
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      "cfres_id": "218850",
      "product_res_number": "Z-1559-2026",
      "event_date_initiated": "2025-12-19",
      "event_date_posted": "2026-03-12",
      "recall_status": "Open, Classified",
      "res_event_number": "98472",
      "product_code": "GTY",
      "product_description": "Wondfo Streptococcal A At-Home Self-Test. At-home test for group A beta-hemolytic streptococcal infection.",
      "code_info": "Model No. 41972; No UDI; Lot Code: 6933289812337.",
      "firm_fei_number": "3042770115",
      "recalling_firm": "Altruan GmbH",
      "address_1": "Morolding 6 6 morolding",
      "city": "Massing",
      "country": "Germany",
      "additional_info_contact": "Customer Service\n87242859602",
      "reason_for_recall": "Product not cleared by the FDA.",
      "root_cause_description": "No Marketing Application",
      "action": "The firm distributed a Recall Notice via email to consignees who purchased affected devices from Altruan's website. The notice instructs consignees to immediately stop using recalled devices and to destroy/dispose of devices in consignee possession. Consignees are to reply to Altruan's email with their order number and confirmation of product disposal to receive a refund.",
      "product_quantity": "188 units",
      "distribution_pattern": "US Nationwide distribution.",
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        "device_name": "Antigens, All Groups, Streptococcus Spp.",
        "medical_specialty_description": "Microbiology",
        "regulation_number": "866.3740",
        "device_class": "1"
      }
    }
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