Vivoo pH Test Recalled Due to Lack of Marketing Clearance and Risk of Inaccurate Results
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Changchun Wancheng Bio-Electron Co., Ltd. has voluntarily recalled 500 Vivoo pH Test strips because they were distributed without legal marketing clearance, posing a risk of false diagnostic 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, MedicalDevice.
What Happened
Changchun Wancheng Bio-Electron Co., Ltd. has initiated a voluntary recall of its Vivoo pH Test strips. The recall was triggered because the devices, which require 510(k) clearance, were distributed to U.S. customers before they could be legally marketed. According to the FDA, these devices may cause false or inaccurate diagnostic results when used by a layperson, which could lead to inappropriate medical interventions.
Which Products Are Affected
The recall affects the following product:
- Product Name: Vivoo pH Test
- Lot Number: 2024013121
- Expiration Date: 01/30/2026
- Quantity: 500 units
- Recall Number: Z-1264-2026
While distribution is listed as nationwide, specific distribution was confirmed in the states of Texas (TX), Georgia (GA), and California (CA).
What You Should Do
Consumers who have purchased the affected Vivoo pH Test strips should stop using the product immediately. The firm initiated the recall via notification letters. For information regarding returns, refunds, or disposal of the product, consumers should contact the recalling firm, Changchun Wancheng Bio-Electron Co., Ltd., located in Changchun, China.
Why This Matters
Using medical diagnostic tests that have not received proper regulatory clearance poses a safety risk, as inaccurate readings can lead users to seek unnecessary medical treatment or fail to seek necessary care based on faulty data.
Source
Information provided by the FDA.
Original source: FDA Official Notice ↗
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