Agency classClass IIOur severity:High FDA (Devices)·Z-2789-2018·Announced 2018-08-22

Wondfo Recalls T-Cube Oral Fluid Test Cubes Due to Choking Hazard

Guangzhou Wondfo Biotech is recalling 50,000 T-Cube One Step Multi-Drug Oral Fluid Test Cubes because the saliva collection device may fail, causing the foam tip to dislodge in the user's mouth.

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 risk-of-harm product (choking hazard) where injury has not yet been reported, which aligns with the 'High' severity criteria in the rubric.

Plain-English summary

Guangzhou Wondfo Biotech Co., Ltd. is recalling 50,000 units of the T-Cube One Step Multi-Drug Oral Fluid Test Cube. The recall was initiated after the manufacturer discovered a potential for failure in the saliva collection device. 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 hazard associated with this recall is that the use of the saliva collection device could cause the foam tip to become dislodged in the user's mouth, creating a choking hazard. The recall involves the SKU/Item Number TCUBE-lOBUP with Lot/Batch Number W61080201. The product was distributed in the state of Virginia.

Consumers who have this product should stop using it immediately. The source text does not specify a specific consumer action such as returning the product or obtaining a refund, but the hazard description implies the device should not be used to prevent injury.

The recalled product

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…
Manufacturer: Guangzhou Wondfo Biotech Co., Ltd.
Category: Medical Device — Diagnostic Test
Hazard: choking
Affected units: 50,000

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-lOBUP
(W61080201)

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

Same hazard · choking