{
  "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": "2026-08-13",
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  "results": [
    {
      "cfres_id": "166754",
      "product_res_number": "Z-0270-2019",
      "event_date_initiated": "2017-09-30",
      "event_date_created": "2018-10-25",
      "recall_status": "Terminated",
      "event_date_terminated": "2019-08-06",
      "res_event_number": "80861",
      "product_code": "NGG",
      "k_numbers": [
        "K082898"
      ],
      "product_description": "Accutest Drug Test Cup 5+3\n\nProduct Usage:\nThe Accutest Drug Test Cup is an in vitro diagnostic test for the rapid detection of multiple drugs in human urine. The test is intended as the first step in a two-step process to provide consumers with information concerning the presence or absence of drugs or their metabolites in a urine sample. Information regarding confirmatory testing- the second step in the process-is provided in the package labeling.",
      "code_info": "Part Number: DS84S625, Lot Number: 174886 (US distribution only)",
      "firm_fei_number": "3003789989",
      "recalling_firm": "Ameditech Inc",
      "address_1": "9940 Mesa Rim Rd",
      "city": "San Diego",
      "state": "CA",
      "postal_code": "92121-2910",
      "additional_info_contact": "858-805-3607",
      "reason_for_recall": "Product was released to market without the adulteration strip included in the product.",
      "root_cause_description": "Nonconforming Material/Component",
      "action": "On September 29, 2017 Ameditech Inc. send notification of the recall informing the customer to do the following:\n1. If you have product in your possession:\n\" Immediately discontinue use and/or sale of affected product lots and place in quarantine.\n\" Complete the enclosed Customer Verification Form, within 10 days, indicating the quantity of\nproduct to be returned from your inventory.\n\" Fax completed Customer Verification Form to 858-677-0243 or scan and e-mail to\namt.fieldaction@alere.com.\n\" Upon receipt of your Customer Verification Form, we will initiate shipment of replacement\nproduct in the quantity indicated on the form and contact you to arrange product return.\n\" Return product as directed.\n2. If you have no remaining product in your possession:\n\" Complete the enclosed Customer Verification Form, within 10 days, indicating \"We do not have\nany affected product.\"\n\" Fax completed Customer Verification Form to 858-677-0243 or scan and e-mail to\namt.fieldaction@alere.com.\n3. Share this information with your staff and retain this notification as part of your records.\nPlease complete this form and return within 10 business days even if you do not have any remaining\nproduct. Send form to Ameditech at Fax Number 858-677-0243 or by e-mail at amt.fieldaction@alere.com.",
      "product_quantity": "40 kit boxes (1000 units)",
      "distribution_pattern": "US in the state of California",
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        "device_name": "Test, Methamphetamine, Over The Counter",
        "medical_specialty_description": "Clinical Toxicology",
        "regulation_number": "862.3610",
        "device_class": "2"
      }
    }
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}