Guangzhou Wondfo Biotech Co., Ltd.: Medical Device Recall in 2018 - (Recall #: Z-2787-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

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 Classification:

Class II

Date Initiated: May 18, 2018

Date Posted: August 22, 2018

Recall Number: Z-2787-2018

Event ID: 80443

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.

Status: Ongoing

Product Quantity: 16,000 units

Code Information:

SKU/Item Number, (Lot/Batch Number) TCUBE-60, (W60680202)

Distribution Pattern:

US Distribution: in the state of VA.

Voluntary or Mandated:

Voluntary: Firm initiated