The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-2787-2018·Announced 2018-08-22

Wondfo Recalls TCube Oral Fluid Drug Test Cubes Due to Choking Hazard

Guangzhou Wondfo Biotech is recalling 16,000 TCube One Step Multi-Drug Oral Fluid Test Cubes because the saliva collection device may fail, causing the foam tip to dislodge and create 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 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 16,000 units of the TCube One Step Multi-Drug Oral Fluid Test Cube. The affected product is identified by SKU/Item Number TCUBE-60 and Lot/Batch Number W60680202. These units were distributed in the state of Virginia.

The recall was initiated because the manufacturer discovered a potential for failure of the saliva collection device. If the device fails during use, the foam tip may become dislodged in the user's mouth, creating a choking hazard.

Consumers who possess this specific product should stop using it immediately. The source text does not provide specific instructions for disposal or return, but users should avoid using the device to prevent injury.

The recalled product

Product
TCube One Step Multi-Drug Oral Fluid Test Cube (AMPSO,COC20,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…
Manufacturer
Guangzhou Wondfo Biotech Co., Ltd.
Category
Medical Device — Diagnostic Test
Hazard
Affected units
16,000

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-60
  • (W60680202)

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 →

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