Wondfo Drug Test Dip Card
Model WDBU-114 · WONDFO USA CO., LTD. · DI 00816862025415
DJG — Enzyme Immunoassay, Opiates · Class II · 21 CFR 862.3650
UDILibrary device dossier · generated 2026-09-14 · sources: FDA GUDID, openFDA (recalls, MAUDE, 510(k)/PMA), FDA Data Dashboard (inspections, compliance actions), 510(k) summary documents.
Recall history (1)
| Initiated | Recall # | Class | Status | Reason | Link basis |
|---|---|---|---|---|---|
| 2022-05-25 | Z-1589-2022 | Class II | Open, Classified | Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21. | code info di |
Adverse-event reports — MAUDE (0)
Caveat (required reading): MAUDE report counts cannot be used to compute incidence rates or compare device safety. Reporting is incomplete, duplicated, and spikes with publicity; there is no denominator of devices in use. The peer line is a reporting baseline (average device in the same product code), not a risk measure.
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2019-01 | 0 | 1 |
| 2019-02 | 0 | 1 |
| 2019-05 | 0 | 1 |
| 2019-06 | 0 | 1 |
| 2019-07 | 0 | 1 |
| 2019-10 | 0 | 2 |
| 2021-07 | 0 | 1 |
| 2022-06 | 0 | 1 |
| 2026-04 | 0 | 1 |
Regulatory clearances
- None linked in the loaded window.
Predicate lineage
K133968 — cites (transitively): K112071 (d1), K020771 (d2)
Lineage extracted from public 510(k) summary text (heuristic).
Manufacturer compliance record — WONDFO USA CO., LTD.
- VAI 2018-05-11 Wondfo USA Co Ltd · 4 citations
- VAI 2018-05-11 Wondfo USA Co Ltd · 4 citations