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

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.