Recall Weekly
Moderate riskFDA DeviceClass II

Vivoo and URIMED urine test strips recalled for inaccuracy risk

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.

From the FDA notice · Read the official notice ↗

What to do

  1. Stop using these test strips immediately
  2. Do not rely on results from affected lots
  3. Consult your doctor if you made health decisions based on these tests
  4. Check lot numbers on your strips—affected lots expire between 01/30/2026 and 10/20/2026
Official notice ↗

Is yours affected?

Compare your label or packaging with the recalled product.

Product
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
Sold in
Nationwide
Made for
Adults (18 years to 100 years)

This recall covers 11 products — see all of them.

Details

Units affected
32,500
Illnesses reported
None reported
Manufactured in
2336, Tianwei Road, Beihu Science and Technology Development Zone, Changchun, N/A, China
Classification
Class II
Recall number
Z-1258-2026

In the FDA's words

Description
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 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. Name/Lot(Expiration): The Girlfriend Doctor Dr. Anna Cabeca Keto-pH-Uric Acid Test Strips/2024032508(03/24/2026), 2024071602(07/15/2026), 2024102108(10/20/2026); URIMED Urinalysis Reagent Strips URS-5, Rapid UTI Test Includes Ketones: Leukocytes, Nitrite, pH, Ketone, Protein/2025043007(04/29/2027); Vivoo Ketone Test/2024013122(01/30/2026) Distribution: US Nationwide distribution in the states of TX, GA, CA. Affected quantity: 32,500
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.

11 products in this recall

LotFancy, Vivoo and URIMED urine test strips recalled over unauthorized marketing

Changchun Wancheng is recalling 11 product listings of home test strips and diagnostic tests, including urinary tract infection, ovulation, menopause, fertility and Vivoo tests. The devices were distributed in the U.S. before FDA clearance (510(k)), and they may give false or inaccurate results to users, which could lead to inappropriate medical treatment. The recall was distributed nationwide, with confirmed distribution in Texas, Georgia and California.

The agency lists each product separately. Check every one you might have.

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