Changchun Wancheng Bio-Electron Recalls Vivoo Sodium, Vitamin C, and Hydration Tests Due to Marketing Violations
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Changchun Wancheng Bio-Electron Co., Ltd. has recalled 3,300 Vivoo diagnostic test strips distributed without legal marketing clearance, posing a risk of inaccurate results.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on April 6, 2026 and geographically references United States. Its severity classification of "medium" signals how the issuing agency weighs the risk of harm if no action is taken - "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.
Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.
Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, fda, MedicalDevices.
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.
Original source: FDA Official Notice ↗
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