Recall Z-2789-2018
Guangzhou Wondfo Biotech Co., Ltd. · initiated May 18, 2018
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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 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.
Codes / lots: SKU/Item Number, (Lot/Batch Number) TCUBE-lOBUP, (W61080201);
Reason for recall
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.
FDA-determined cause: Nonconforming Material/Component
Action taken
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 form as soon as possible by faxing. to 123-456-7890,or by scanning and e-mailing to TOX.FCA@alere.com. They also stated to complete and return the form even if the customer may have consumed or distributed all affected product. Any questions should be directed toward Alere Toxicology Services Phone: 123-456-7890, Email:FCA.TOX@alere.com.
Details
- Recall number
- Z-2789-2018
- Initiated
- May 18, 2018
- Product code
- DIS – Enzyme Immunoassay, Barbiturate
- Quantity
- 50,000 units
- Distribution
- US Distribution: in the state of VA.
- Recalling firm
- Guangzhou Wondfo Biotech Co., Ltd., GuangZhou
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-2787-2018 Class II | TCube One Step Multi-Drug Oral Fluid Test Cube (AMPSO,COC20,METSO, OPl40,OXY20,THC2S)…GUANGZHOU WONDFO BIOTECH discovered on the TCube One Step Multi-Drug Oral Fluid Test Cube the potential for… | 05/18/2018Open, Classified |
| Z-2788-2018 Class II | TCube One Step Multi-Drug Oral Fluid Test Cube (AMPSO, BARGO, BZ030,COC20,MDMA100,METSO…GUANGZHOU WONDFO BIOTECH discovered on the TCube One Step Multi-Drug Oral Fluid Test Cube the potential for… | 05/18/2018Open, Classified |