{
  "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": "2026-08-27",
    "results": {
      "skip": 0,
      "limit": 1,
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  "results": [
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      "product_res_number": "Z-0814-03",
      "event_date_initiated": "2003-03-12",
      "event_date_posted": "2003-05-14",
      "recall_status": "Terminated",
      "event_date_terminated": "2005-02-03",
      "res_event_number": "25574",
      "product_code": "JPA",
      "k_numbers": [
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      "product_description": "CoaguChek Plus meter; catalog # 475729 and 12816001.",
      "code_info": "All units",
      "firm_fei_number": "1823260",
      "recalling_firm": "Roche Diagnostics Corp.",
      "address_1": "9115 Hague Road",
      "city": "Indianapolis",
      "state": "IN",
      "postal_code": "46250-0457",
      "additional_info_contact": "800-428-4674",
      "reason_for_recall": "High frequency signals from other medical or communications equipment will result in a variable positive bias in test results.",
      "root_cause_description": "Other",
      "action": "Urgent Product Removal letters dated 3/12/03 were sent to all customers.  Distributors were asked to conduct a recall from their customers.  Replacement meters are not currently available from Roche.  Roche will temporarily provide a CoaguChek S system to run PT samples and will reimburse for APTT and ACT tests that are sent to an accredited outside laboratory.",
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      "distribution_pattern": "United States",
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