FDA-Device2026-02-11Class IIMISBRANDING
Multiple UTI test strip brands recalled for inaccurate results and unapproved marketing
What this means
Several brands of over-the-counter urinary tract infection test strips were sold in the U.S. without proper FDA approval. These strips may give false or inaccurate results, which could lead to wrong treatment decisions or missed infections.
- Stop using LotFancy, PALINOIA, Vaunn Medical, JNW Direct, or Urinify UTI/urinalysis test strips
- Check the lot numbers and expiration dates on your package against the FDA recall list
- Discard the affected strips
- Contact your doctor if you used these strips and need proper UTI testing
The agency's original wording
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.
Intended for
All ages
Illnesses reported
None reported
Sold states
US Nationwide distribution in the states of TX, GA, CA.
Affected count
91,366
Manufactured in
2336, Tianwei Road, Beihu Science and Technology Development Zone, Changchun, N/A, China
Products
LotFancy Urinary Tract Infection Urine (UTI) Test Strips; PALINOIA UTI-10 PARAMETER REAGENT STRIPS; Vaunn Medical 8-in-1 Urinalysis Reagent Strip; JNW Direct 4-in-1 UTl Urinalysis Test Strips; Urinify STRENGTH; Urinify ESSENTIAL, Urinify Urinary Tract Infection (UTI)
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1257-2026Want us to check the next one for you?
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