RegWardenFDA facility compliance records
Facility

GUANGZHOU WONDFO BIOTECH CO., LTD.

1 recall(s) on record — most severe on record: Class II.

Activity by year

FDA actions on record by year2018: 1 recalls20171201820192020202120222023202420252026
  • Recalls (1)

Devices registered here (1)

  • Simple Point-Of-Care Device To Directly Detect Sars-Cov-2 Viral Targets From Clinical Specimens In Near-Patient Settings
    Product code QVF (opens in a new tab) · Class II · Microbiology · 21 CFR 866.3982

Recalls & enforcement

  • Class IIOngoing2018-05-18
    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 hazar…

Related

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “GUANGZHOU WONDFO BIOTECH CO., LTD. (FEI 3004635103) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3004635103-guangzhou-wondfo-biotech-co-ltd/

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