FDA Device recall Z-2787-2018
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…
- FDA Device
- Class II
- ongoing
- Published 2018-08-22
On 2018-08-22 the FDA classified a Class II recall of 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… by Guangzhou Wondfo Biotech, citing 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 collecti….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2787-2018 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2018-05-18 |
| Published | 2018-08-22 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Guangzhou Wondfo Biotech |
| Distribution | VA |
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 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.
Reason
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.
Identifiers
| code_info | SKU/Item Number, (Lot/Batch Number) TCUBE-60, (W60680202) |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2787-2018%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.