Changchun Wancheng Bio-Electron Recalls Vivoo Sodium, Vitamin C, and Hydration Tests Due to Marketing Violations

What Happened

Changchun Wancheng Bio-Electron Co., Ltd. has initiated a voluntary recall of several Vivoo diagnostic test strips. The products, which include sodium, vitamin C, and hydration tests, were distributed to U.S. customers before they could be legally marketed or receive the required 510(k) clearance. According to the FDA, these devices may produce false or inaccurate diagnostic results when used by consumers, which could lead to inappropriate medical interventions.

Which Products Are Affected

The recall involves approximately 3,300 units distributed nationwide, with specific distribution identified in Texas, Georgia, and California. The following products and lots are affected:

• Vivoo Sodium Test: Lot 2024013123 (Expiration: 01/30/2026)
• Vivoo Vitamin C Test: Lot 2024013124 (Expiration: 01/30/2026)
• Vivoo Hydration Test: Lot 2024013119 (Expiration: 01/30/2026) and Lot 2025051519 (Expiration: 05/14/2027)

What You Should Do

Consumers who have purchased these Vivoo test strips should stop using them immediately. The recalling firm initiated notification to customers via letter on November 22, 2025. For information regarding returns or further guidance, consumers should contact Changchun Wancheng Bio-Electron Co., Ltd. directly. The recall has been assigned the official number Z-1267-2026.

Why This Matters

The use of diagnostic tests that have not been cleared for legal marketing poses a safety risk because their accuracy cannot be guaranteed. Inaccurate readings may cause users to seek unnecessary medical treatment or fail to seek necessary care based on false data.

Source

This information is based on the official recall notice from the FDA.