{
  "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": "2026-04-22",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "GuangZhou",
      "state": "",
      "country": "China",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "80443",
      "recalling_firm": "Guangzhou Wondfo Biotech Co., Ltd.",
      "address_1": "No.8 LiZhiShan Road,",
      "address_2": "Science City, LuoGang District",
      "postal_code": "N/A",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "US Distribution: in the state of VA.",
      "recall_number": "Z-2787-2018",
      "product_description": "TCube One Step Multi-Drug Oral Fluid Test Cube (AMPSO,COC20,METSO, OPl40,OXY20,THC2S)    Product Usage:  T-Cube¿ One Step Multi-Drug Oral Fluid Test Cube is a rapid oral fluid screening test. The test is a lateral flow, one-step immunoassay for the qualitative detection of specific drugs and their metabolites in human oral fluid at the following cut off concentrations for use in employment and insurance testing. The assay provides a qualitative, preliminary test result. A more specific analytical method must be used in order to obtain a confirmed result. Gas Chromatography/Mass Spectrometry (GC/MS) or Liquid Chromatography/Tandem Mass Spectrometry (LC/MS-MS) are preferred confirmatory methods. Professional judgment should be applied to any drug test result, particularly when preliminary results are positive.",
      "product_quantity": "16,000 units",
      "reason_for_recall": "GUANGZHOU WONDFO BIOTECH discovered on the TCube One Step Multi-Drug Oral Fluid Test Cube the  potential for failure of the saliva collection device.  The use of the saliva collection device could cause the foam tip to become dislodged in the user's mouth creating a choking hazard.",
      "recall_initiation_date": "20180518",
      "center_classification_date": "20180811",
      "report_date": "20180822",
      "code_info": "SKU/Item Number, (Lot/Batch Number)    TCUBE-60, (W60680202)",
      "more_code_info": ""
    }
  ]
}