Z-2789-2018Class II

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

Name: Z-2789-2018 TCube One Step Multi-Drug Oral Fluid Test Cube (AMPSO, BARGO, SUPS, BZ030, COC20,MDMAlOO, METSO...
Creator: Guangzhou Wondfo Biotech Co., Ltd.
Published: 2018-05-18
License: https://open.fda.gov/license/

Guangzhou Wondfo Biotech Co., Ltd. / initiated 2018-05-18 / Open, Classified / root cause: manufacturing process

FDA source

Guangzhou Wondfo Biotech Co., Ltd. began a recall of 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... on 2018-05-18. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2789-2018
Classification: Class II
Status: Open, Classified
Initiated: 2018-05-18
Posted: 2018-08-12
Recalling firm: Guangzhou Wondfo Biotech Co., Ltd.
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.
Product code: DIS Enzyme Immunoassay, Barbiturate
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.
Root cause tag: manufacturing process
FDA 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 [email protected]. 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:[email protected].
Quantity in commerce: 50,000 units
Distribution: US Distribution: in the state of VA.
Product codes and lots: SKU/Item Number, (Lot/Batch Number) TCUBE-lOBUP, (W61080201);

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2789-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2787-2018	Class II	Ongoing	Voluntary: Firm initiated	2018-08-22	2018-08-11
Z-2788-2018	Class II	Ongoing	Voluntary: Firm initiated	2018-08-22	2018-08-11
Z-2789-2018	Class II	Ongoing	Voluntary: Firm initiated	2018-08-22	2018-08-11

Product code DIS

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)