FDA-Device2026-02-11Class IIMISBRANDING
Vivoo pH Test strips recalled for unapproved distribution and inaccurate results
FALSE CLAIMSNationwide distribution
Stop using Vivoo pH Test strips
Vivoo pH Test strips were sold in the U.S. before receiving required FDA approval. The strips may give false or inaccurate results, which could lead to inappropriate medical decisions based on incorrect findings.
- Stop using your Vivoo pH Test strips immediately
- Contact Changchun Wancheng Bio-Electron Co., Ltd. or your retailer for instructions on returning the product
- Consult a healthcare provider if you made health decisions based on test results from this product
Hazard
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.
Sold states
US Nationwide distribution in the states of TX, GA, CA.
Affected count
500
Manufactured in
2336, Tianwei Road, Beihu Science and Technology Development Zone, Changchun, N/A, China
Products
Vivoo pH Test
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1264-2026Don't want to check this manually?
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