Recall Z-2788-2018 ยท DIS Enzyme Immunoassay, Barbiturate
Guangzhou Wondfo Biotech Co., Ltd.
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 qualitative detection of specific drugs and their metabolites in human oral fluid at the following cut off concentrations for
| Date | May 18, 2018 |
| Status | Open, Classified |
| 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. |
| Root cause | Nonconforming Material/Component |
| Action | The firm notified its customers on or about 05/22/2018 via a letter entitled "URGENT MEDICAL DEVICE RECALL". The firm advised the end user to examine their inventory and quarantine product subject to recall. In addition, if they have further distributed this product, please identify the customers and notify them at once of this product recall. The notification to customers may be enhanced by including a copy of the recall notification letter. The firm advised the end user to follow the directions indicated in the "Customer Required Action" section below and return the completed response fo |
| Quantity | 60,000 units |
| Distribution | US Distribution: in the state of VA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.