Vivoo Sodium Test; Vivoo Vitamin C Test; Vivoo Hydration Test
Recall
- Recall Number
- Z-1267-2026
- Event Number
- 97801
- Firm
- Changchun Wancheng Bio-Electron Co., Ltd. 2336, Tianwei Road Beihu Science and Technology Development Zone Changchun China
- FEI Number
- 3008987086
- Product Code
- JJW
- Status
- Open, Classified
- Root Cause
- No Marketing Application
- Initiated
- November 22, 2025
- Posted
- February 4, 2026
Description
Vivoo Sodium Test; Vivoo Vitamin C Test; Vivoo Hydration Test
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.
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: [email protected] Questions can be emailed to the firm at: [email protected] / [email protected]
US Nationwide distribution in the states of TX, GA, CA.
3,300