FDA-Device2026-02-11Class IIMISBRANDING
Vivoo Protein Test strips recalled for unapproved marketing, risk of inaccurate results
FALSE CLAIMSNationwide distribution
Stop using Vivoo Protein Test strips
Vivoo Protein Test strips were sold in the U.S. before receiving required FDA approval. The tests may give false or inaccurate results, which could lead to unnecessary medical decisions based on incorrect information.
- Stop using your Vivoo Protein Test strips immediately
- Do not rely on results from lot 2024013122
- Contact your healthcare provider if you used this test and made health decisions based on the results
- Contact Changchun Wancheng Bio-Electron Co., Ltd. for instructions on returning the 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 Protein Test
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1265-2026Don't want to check this manually?
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