Product Wiki · Recalls · U.S. FDA — Device Enforcement

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 detectio — recall Z-2789-2018

U.S. FDA — Device Enforcement · China · 2018-05-18 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2789-2018
Date of alert
2018-05-18
Country / jurisdiction
China
Risk level
Class II
Risk type
recall
Brand
Guangzhou Wondfo Biotech Co., Ltd.
Product category
device
Product type
Devices
Reported risk: 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.
Primary source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&

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ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.