Device recall
Z-2789-2018: TCube One Step Multi-Drug Oral Fluid Test Cube (AMPSO, BARGO, SUPS, BZ030…
FDA device recall · Class II · Guangzhou Wondfo Biotech Co., Ltd.
Key facts
| Recall number (Z-number) | Z-2789-2018 |
|---|---|
| Recall event | 80443 |
| 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… |
| Product code | DIS |
| Recalling firm | Guangzhou Wondfo Biotech Co., Ltd. |
| Recall class | Class II |
| Status | Open, Classified |
| FEI number | 3004635103 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database