Vivoo Sodium Test; Vivoo Vitamin C Test; Vivoo Hydration Test

FDA device recall Z-1267-2026 · posted 2026-02-04 · Open, Classified

Recall details

Recalling firm

Changchun Wancheng Bio-Electron Co., Ltd.

Reason for recall

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.

Action taken

Starting on 11/22/2025, recall notices were mailed or emailed to customers/distributors who were asked to do the following: 1) Destroy unused devices. 2) Inform customers that test results may be inaccurate, and it is recommended to re-test. 3) If affected devices were further distributed, please forward this notice and response form to these additional customers or email us a customer distribution list with names, emails, addresses, phone numbers so we can notify your customers of the recall. 4) Complete and return the Acknowledgement and Receipt Form via email to: sales04@ccwancheng.com Questions can be emailed to the firm at: sales01@ccwancheng.com / sales04@ccwancheng.com

Root cause

No Marketing Application

Status

Open, Classified

Product code

JJW

Quantity affected

3,300

Distribution

US Nationwide distribution in the states of TX, GA, CA.

Date initiated

2025-11-22

Date posted

2026-02-04

Location

Changchun, Beihu, China