Guangzhou Wondfo Biotech Co., Ltd.: 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.

Recall number

Z-2787-2018

Recalling firm

Guangzhou Wondfo Biotech Co., Ltd.

Product

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.

Status

Open, Classified

Initiated

2018-05-18

Posted

not on file

Terminated

not on file

Reason

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.

Root cause

Nonconforming Material/Component

Action

The firm notified its customers on or about 05/22/2018 via a letter entitled "URGENT MEDICAL DEVICE RECALL". The firm advised the end user to examine their inventory and quarantine product subject to recall. In addition, if they have further distributed this product, please identify the customers and notify them at once of this product recall. The notification to customers may be enhanced by including a copy of the recall notification letter. The firm advised the end user to follow the directions indicated in the "Customer Required Action" section below and return the completed response form as soon as possible by faxing. to 123-456-7890,or by scanning and e-mailing to TOX.FCA@alere.com. They also stated to complete and return the form even if the customer may have consumed or distributed all affected product. Any questions should be directed toward Alere Toxicology Services Phone: 123-456-7890, Email:FCA.TOX@alere.com.

Quantity

16,000 units

Distribution

US Distribution: in the state of VA.

Lot, serial or model codes

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

510(k) numbers

not on file

PMA numbers

not on file

Product code

DIS

Firm FEI

3004635103

Firm city

GuangZhou

Firm state

not on file

Firm country

China

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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