FDAHealthNovember 22, 2025
Changchun Wancheng Bio-Electron Co., Ltd. — Vivoo Vaginal pH Test
⚠️ 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.
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- November 22, 2025
US Nationwide distribution in the states of TX, GA, CA.
What's affected?
- Product
- Vivoo Vaginal pH Test
- Lot code
- (Expiration):
Additional details
Name/Lot(Expiration): Vivoo Vaginal pH Test/2024032219(03/21/2026)
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 3,000.
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