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U.S. Department of Health and Human Services

Class 2 Device Recall TCube One Step MultiDrug Oral Fluid Test Cube

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  Class 2 Device Recall TCube One Step MultiDrug Oral Fluid Test Cube see related information
Date Initiated by Firm May 18, 2018
Create Date August 12, 2018
Recall Status1 Open3, Classified
Recall Number Z-2789-2018
Recall Event ID 80443
Product Classification Enzyme immunoassay, barbiturate - Product Code DIS
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.
Code Information SKU/Item Number, (Lot/Batch Number)  TCUBE-lOBUP, (W61080201);  
Recalling Firm/
Manufacturer		 Guangzhou Wondfo Biotech Co., Ltd.
No.8 LiZhiShan Road,
Science City, LuoGang District
GuangZhou China
For Additional Information Contact
086-02032299999
Manufacturer 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.
FDA Determined
Cause 2		 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 in Commerce 50,000 units
Distribution US Distribution: in the state of VA.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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