Vivoo pH Test Recalled Due to Lack of Marketing Clearance and Risk of Inaccurate Results

Source: FDA · United States

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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 February 18, 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 regulatory framework behind it, which shapes what remedies (refunds, replacements, recalls, evacuations) are available to affected individuals and who 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 read it as a data point about the issuing system: how quickly FDA detected the hazard, how precise the geographic or product-identifier scope is, and whether similar notices have clustered in the same category or region in the last 90 days. Cluster patterns frequently precede a broader regulatory action — a single localized FDA recall is isolated; three of them within a quarter often indicate a supply-chain, infrastructure, or seasonal driver that will keep producing notices until something structural changes.

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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 ↗

All FDA Recalls →

Frequently Asked Questions

Common questions about this FDA recall.

What is this FDA recall about?
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.
Which agency issued this alert?
This alert was issued by FDA. The original notice is available at the source link at the bottom of this article.
How severe is this alert?
This alert is classified as "medium" severity. Stay informed and follow agency guidance.
What area is affected?
This alert affects United States. Check with FDA for the most current geographic scope.
Where can I find more FDA Recalls updates?
Browse the full FDA Recalls feed on Areazine at areazine.com/recalls/fda/ for the latest updates from FDA and other agencies.