FDA-Device2026-02-11Class IIMISBRANDING
Girlfriend Doctor, URIMED, and Vivoo urine test strips recalled for inaccurate results
FALSE CLAIMSNationwide distribution
Stop using these urine test strips
The FDA found that Girlfriend Doctor Dr. Anna Cabeca Keto-pH, URIMED Urinalysis Reagent Strips URS-5, and Vivoo Ketone test strips were sold without proper FDA approval. These tests can give false or inaccurate results, which may lead to wrong medical decisions.
- Stop using these test strips immediately
- Do not rely on results from affected lots
- Consult your doctor if you made health decisions based on these tests
- Check lot numbers on your strips—affected lots expire between 01/30/2026 and 10/20/2026
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
32,500
Manufactured in
2336, Tianwei Road, Beihu Science and Technology Development Zone, Changchun, N/A, China
Products
The Girlfriend Doctor Dr. Anna Cabeca Keto-pH-Uric Acid Test Strips; URIMED Urinalysis Reagent Strips URS-5, Rapid UTI Test Includes Ketones: Leukocytes, Nitrite, pH, Ketone, Protein; Vivoo Ketone Test
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1258-2026Don't want to check this manually?
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