{
  "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": "2026-08-22",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "106374",
      "product_res_number": "Z-0868-2012",
      "event_date_initiated": "2011-08-23",
      "event_date_posted": "2012-01-25",
      "recall_status": "Terminated",
      "event_date_terminated": "2012-01-25",
      "res_event_number": "60743",
      "product_code": "DKB",
      "k_numbers": [
        "K051088"
      ],
      "product_description": "Multi-Analyte Urine DAU Calibrator (15 mL HDPE bottle inside a cardboard box)\r\nFor in vitro diagnostic use only.\r\n\r\nLin-Zhi International, Inc..\r\n670 Almanor Ave.\r\nSunnyvale, CA 94085\r\n\r\nintended use: Drug abuse detection.",
      "code_info": "Catalog number 0803; Lot  1101136K3, exp 1/28/13",
      "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": "Multi Analyte Urine DAU Cutoff Calibrator Gives a decreased absorbance reading due to a loss of the BZO (oxazepam) analyte from the solution and may cause false positive readings.",
      "root_cause_description": "Nonconforming Material/Component",
      "action": "The firm, Lin-Zhi International, Inc., sent a notice by email dated August 23, 2011 to all customers.  The notice described the product, problem and actions to be taken. Lin-Zhi will contact the customers to determine whether they want replacement BZO calibrators and controls immediately or if they are willing to wait a minimum of four weeks for a new lot of the Multi-Analyte Urine Cutoff Calibrators.  The customers were instructed to contact Lin-Zhi with their replacement request.\r\n\r\nThe notice also stated that the Lin-Zhi has plans to create more stringent QC standards and further R&D regarding stabilization of this analyte in solution in its calibrators of controls containing BZO.\r\n\r\nIf you have any questions or concerns regarding how this situation is being handled or the outcome, contact Lin-Zhi at (408)732-3856; email: customerservice@lin-zih.com or webpage: www.lin-zhi.com.",
      "product_quantity": "45 items",
      "distribution_pattern": "Worldwide distribution: USA (nationwide) including states of: AL, FL, GA, IN, NC, NH, and TX; and country of: Germany.",
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        "registration_number": [
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        "fei_number": [
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        "device_name": "Calibrators, Drug Mixture",
        "medical_specialty_description": "Clinical Toxicology",
        "regulation_number": "862.3200",
        "device_class": "2"
      }
    }
  ]
}