Class II — Changchun Wancheng Bio-Electron Co., Ltd.
| Recalling firm | Changchun Wancheng Bio-Electron Co., Ltd. |
|---|---|
| Registered facility | CHANGCHUN WANCHENG BIO-ELECTRON CO., LTD. (the firm's only registered facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | Test strips and other tests including for near-patient testing, that require a 510(k) were distributed before they could be legally marketed to U.S. customers; devices may cause false or inaccurate diagnostic result by lay person and lead to inappropriate medical intervention. |
| Product | Vivoo Sodium Test; Vivoo Vitamin C Test; Vivoo Hydration Test |
| Quantity | 3,300 |
| Distribution | US Nationwide distribution in the states of TX, GA, CA. |
| Initiated | 2025-11-22 |
| Classified | 2026-02-04 |
| Recall number | Z-1267-2026 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Changchun Wancheng Bio-Electron Co., Ltd. (Z-1267-2026).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/97801/
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