Agency classClass IIOur severity:High FDA (Devices)·Z-2788-2018·Announced 2018-08-22

Wondfo Recalls TCube Oral Fluid Test Cube Due to Choking Hazard

Guangzhou Wondfo Biotech is recalling 60,000 units of the TCube One Step Multi-Drug Oral Fluid Test Cube because the saliva collection device may dislodge, creating a choking hazard.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a choking hazard, which is a risk-of-harm product where injury has not yet been reported, fitting the criteria for a High severity score.

Plain-English summary

Guangzhou Wondfo Biotech Co., Ltd. is recalling 60,000 units of the TCube One Step Multi-Drug Oral Fluid Test Cube. The recall was initiated after the company discovered a potential for failure in the saliva collection device.

The hazard involves the foam tip of the saliva collection device becoming dislodged in the user's mouth, which creates a choking hazard. The affected product is a rapid oral fluid screening test used for the qualitative detection of specific drugs and their metabolites in human oral fluid.

The recalled units were distributed in the state of Virginia. The specific lot number is W61080202, and the SKU/Item Number is TCUBE-lOMO. Consumers who have this product should stop using it immediately to avoid the risk of choking.

The recalled product

Product: TCube One Step Multi-Drug Oral Fluid Test Cube (AMPSO, BARGO, BZ030,COC20,MDMA100,METSO, MTD30,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…
Manufacturer: Guangzhou Wondfo Biotech Co., Ltd.
Category: Medical Device — Diagnostic Test
Hazard: choking
Affected units: 60,000

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (3)

SKU/Item Number
(Lot/Batch Number) TCUBE-lOMO
(W61080202)

Distribution

Distributed in 2 states:

Part of a larger recall action

This product is one of 3 recalled by Guangzhou Wondfo Biotech Co., Ltd. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 3 products in this recall →

Same manufacturer · Guangzhou Wondfo Biotech Co., Ltd.

See all →

High
Wondfo Recalls T-Cube Oral Fluid Test Cubes Due to Choking Hazard
FDA (Devices) · 2018-08-22
High
Wondfo Recalls TCube Oral Fluid Drug Test Cubes Due to Choking Hazard
FDA (Devices) · 2018-08-22

Same hazard · choking