Guangzhou Wondfo Biotech Co., Ltd.
No.8 Lizhishan Road, Science City, Huangpu District, Guangzhou Guangdong, CN
Registered product codes
44 product codes
Recent MDR events
16 on file
- PREVIEW® STREP A TEST KITJul 1, 2025Malfunction3007606081-2025-00001
- CLARITY DIAGNOSTICS LLC, CLARITY STREP A RAPID TEST STRIPJul 1, 2025Malfunction3007606081-2025-00003
- IMCO STREP A RAPID TEST STRIPJul 1, 2025Malfunction3007606081-2025-00004
- EASY AT HOME MEDICAL LLC, ARETA ONE STEP STREP A SWAB TJul 1, 2025Malfunction3007606081-2025-00002
- WONDFO BIOTECH CO. SARS-COV-2 ANTIBODY TESTMay 27, 2020MalfunctionMW5094699
- ONE STEP MULTI-DRUG ORAL FLUID TEST CUBEJun 27, 2018Malfunction3004635103-2018-52510
- ONE STEP MULTI-DRUG ORAL FLUID TEST CUBEJun 27, 2018Malfunction3004635103-2018-52508
- ONE STEP MULTI-DRUG ORAL FLUID TEST CUBEJun 27, 2018Malfunction3004635103-2018-52509
- ONE STEP MULTI-DRUG ORAL FLUID TEST CUBEJun 27, 2018Malfunction3004635103-2018-52506
- ONE STEP MULTI-DRUG ORAL FLUID TEST CUBEJun 27, 2018Malfunction3004635103-2018-52507
Recalls
3 on file
- Open, ClassifiedUnknown
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.
View FDA record ↗ - Open, ClassifiedUnknown
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.
View FDA record ↗ - Open, ClassifiedUnknown
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.
View FDA record ↗
Compliance history
Matched by FEI 3004635103.
FDA inspections
0 on file
No inspections on file for this FEI number.
Inspection citations
0 on file
No citations on file for this FEI number.
Compliance actions
0 on file
No warning letters or injunctions on file for this FEI number.
Import refusals
1 on file
Top refusal reasons
Compare to industry ↗- Division of Southeast Imports (DSEI)May 6, 2025
83QYT \ OVER-THE-COUNTER COVID-19 ANTIGEN TEST