FDA recall Z-2789-2018

Guangzhou Wondfo Biotech Co., Ltd. · Class II · device

Product

TCube One Step Multi-Drug Oral Fluid Test Cube (AMPSO, BARGO, SUPS, BZ030, COC20,MDMAlOO, 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.

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.

Distribution

US Distribution: in the state of VA.

Key facts

Status
Ongoing
Initiation date
2018-05-18
Report date
2018-08-22
Voluntary/Mandated
Voluntary: Firm initiated
Location
GuangZhou, China

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2789-2018