{
  "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": "2026-08-20",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "106403",
      "product_res_number": "Z-0847-2012",
      "event_date_initiated": "2011-10-11",
      "event_date_posted": "2012-01-25",
      "recall_status": "Terminated",
      "event_date_terminated": "2012-01-25",
      "res_event_number": "60757",
      "product_code": "DKB",
      "k_numbers": [
        "K051088"
      ],
      "product_description": "Multi-Analyte Urine DAU Calibrator (15 mL);\nMulti-Analyte,Intermediate Calibrator;\nfor in-vitro diagnostic use only.\nContains 300 ng/mL benzoylecgonine, 750 ng/mL d-methamphetamine, 4000 ng/m: morphine, 50 phencyclidine, 500 ng/m: oxazepam, 500 ng/mL secobarbital, 700ng/mL propoxyphene and 600 ng.mL methadone in urine buffer with dosium azide as preservitive.\n\nDrug abuse testing\n\nLin-Zhi International, Inc.'\n670 Almanor Ave.\nSunnyvale, CA 94085.",
      "code_info": "Catalog 0804;  lot number 1101138K2, exp 1/28/2013",
      "firm_fei_number": "3003610499",
      "recalling_firm": "Lin-Zhi International Inc",
      "address_1": "670 Almanor Ave",
      "city": "Sunnyvale",
      "state": "CA",
      "postal_code": "94085-3513",
      "additional_info_contact": "Annie Hung\n408-732-3856",
      "reason_for_recall": "Catalog # 0804 Multi-Analyte Urine DAU Intermediate Calibrators were incorrectly labeled and mistakenly filled with Catalog # 0805 DAU High Calibrators.",
      "root_cause_description": "Labeling mix-ups",
      "action": "Lin -Zhi International sent a Recall letter dated  October 11, 2011, and a e-mail to all affected customers.  This was followed up by a personal phone call from Lin-Zhi personnel. The letter identified the product the problem and the action needed to be taken by the customer. \n\nThe customer will be contacted to determine whether or not they were affected by this non-conformity. If they have been affected, they will be offered replacement Multi-Analyte Urine Intermediate Calibrators which are currently estimated to have a four week wait time before they become available.\n\nFor further questions please call  (408) 732-3856.",
      "product_quantity": "49 items",
      "distribution_pattern": "Worldwide Distribution -- USA (nationwide) including the states of NC,MA, NH and  TX. and the country of  Germany,",
      "openfda": {
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        "device_name": "Calibrators, Drug Mixture",
        "medical_specialty_description": "Clinical Toxicology",
        "regulation_number": "862.3200",
        "device_class": "2"
      }
    }
  ]
}