Vivoo recalled 3,000 vaginal pH tests on November 22, 2025. The tests may cause false results leading to inappropriate medical interventions. The products 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 Vaginal pH Test allows consumers to check their vaginal pH levels at home, which can be useful for monitoring health. Consumers typically purchase these tests for personal health management and to understand vaginal health better.
The test strips may yield inaccurate results, especially when used by individuals without medical training. This can lead to misinterpretation of results and unnecessary medical actions.
This recall is not part of a broader industry pattern.
Consumers who purchased this test may face health risks due to inaccurate results. The need to stop use and return the product can also cause inconvenience.
The model number is typically found on the packaging or the test strips themselves.
Expect a refund or replacement processing time of approximately 4-6 weeks.
Keep a record of your purchase receipt, any correspondence with the manufacturer, and photos of the product.
The recall involves the Vivoo Vaginal pH Test, model Vivoo Vaginal pH Test/2024032219, with an expiration date of March 21, 2026. The product was distributed nationwide in the U.S. and is manufactured by Changchun Wancheng Bio-Electron Co. It was not legally marketed before its distribution.
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