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 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.
The Vivoo pH Test strips may yield false or inaccurate diagnostic results when used by laypersons. This misdiagnosis could result in inappropriate medical interventions, posing a high risk to consumers.
No specific incidents of injury or death have been reported at this time. However, the potential for misdiagnosis raises serious health concerns.
Consumers should stop using the Vivoo pH Test immediately. Follow the recall instructions provided by the manufacturer and contact Changchun Wancheng Bio-Electron Co. or your healthcare provider for further guidance.
For more information, contact Changchun Wancheng Bio-Electron Co. at the provided link. Further details can be accessed at the FDA enforcement report link.
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