{
  "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": "2026-04-01",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "San Diego",
      "state": "CA",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "86335",
      "recalling_firm": "Ameditech Inc",
      "address_1": "9940 Mesa Rim Rd",
      "address_2": "N/A",
      "postal_code": "92121-2910",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "US - Nationwide  OUS - Australia, France, Germany, New Zealand, Singapore and Spain",
      "recall_number": "Z-3029-2020",
      "product_description": "Alere iScreen Single Drug Detection (AMT Item Number/ AMT Description):   X11-IS1 BUP-DX/ \"Alere iScreen\" Dx Single Dip Card Single Drug Detection: Buprenorphine (BUP)\",  X11-IS1 BAR-DX /\"Alere iScreen\" Dx Single Dip Card  Single Drug Detection: Barbiturate (BAR)\",  X11-IS1 OXY-DX /\t\"Alere iScreen¿ Dx Single Dip Card  Single Drug Detection: Oxycodone (OXY)\",  X11-IS1 BZO-DX / \"Alere iScreen\" Dx Single Dip Card  Single Drug Detection: Benzodiazepine (BZO300)\",  X11-IS1 MET-DX /\t\"Alere iScreen¿ Dx Single Dip Card  Single Drug Detection: Methamphetamine (MET)\",  X11-IS1 AMP-DX /\"Alere iScreen¿ Dx Single Dip Card  Single Drug Detection: Amphetamine (AMP)\",  X11-IS1 MDM-DX /\t\"Alere iScreen¿ Dx Single Dip Card  Single Drug Detection: Ecstasy (MDMA)\",  X11-IS1 MTD-DX /\"Alere iScreen¿ Dx Single Dip Card  Single Drug Detection: Methadone (MTD)\",  X11-IS1 MOP-DX/\"Alere iScreen¿ Dx Single Dip Card  Single Drug Detection: Morphine (MOP)\",  X11-IS1 THC-DX/\"Alere iScreen¿ Dx Single Dip Card  Single Drug Detection: Marijuana (THC)\",  X11-IS1 TCA-DX/\t\"Alere iScreen¿ Dx Single Dip Card  Single Drug Detection: Tricyclic Antidrepessants (TCA)\",  X11-IS1 PCP-DX\t/\"Alere iScreen¿ Dx Single Dip Card  Single Drug Detection: Phencyclidine (PCP)\",",
      "product_quantity": "303,100 units",
      "reason_for_recall": "Various immunoassay enzymes failed product performance, thereby the products do not consistently detect all calibrator and secondary compounds at the levels stated in the labeling.",
      "recall_initiation_date": "20200818",
      "center_classification_date": "20200930",
      "termination_date": "20240930",
      "report_date": "20201007",
      "code_info": "ALL Lots Within Expiry"
    }
  ]
}