Changchun Wancheng Bio-Electron Co. recalled 500 Vivoo pH Test strips on November 22, 2025. The recall follows concerns over false diagnostic results that could lead to inappropriate medical interventions. These devices were distributed nationwide, including Texas, Georgia, and California.
Test strips and other tests including for near-patient testing, that require a 510(k) were distributed before they could be legally marketed to U.S. customers; devices may cause false or inaccurate diagnostic result by lay person and lead to inappropriate medical intervention.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Changchun Wancheng Bio-Electron Co., Ltd. or your healthcare provider for instructions. Notification method: Letter
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The Vivoo pH Test is a medical device used for monitoring pH levels, which can be important for various health assessments. Consumers typically use these test strips at home for quick health insights.
The hazard arises because the test strips were distributed without appropriate FDA clearance, potentially leading to incorrect pH readings. Such inaccuracies can result in improper health decisions.
This recall is not part of a broader industry pattern.
The recall affects consumers who rely on accurate pH testing for health monitoring. The potential risk of incorrect readings could lead to unnecessary medical interventions.
You can find the model number and expiration date on the product packaging or insert included with the test strips.
Expect to receive a refund or further instructions within 4-6 weeks after contacting the manufacturer.
Keep records of your purchase, including receipts and any correspondence with the manufacturer regarding the recall.
The recalled product is the Vivoo pH Test, model Vivoo pH Test/2024013121, with an expiration date of January 30, 2026. The device was distributed nationwide in the U.S. The recall affects 500 units.
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