Recall Weekly
Moderate riskFDA DeviceClass II

Vivoo test strips recalled for possible inaccurate results

Vivoo urine test strips for sodium, vitamin C, and hydration were sold without required FDA approval and may provide false or inaccurate results. These tests are designed for home use and incorrect results could lead to unnecessary medical decisions. The affected products have specific lot numbers and expiration dates in 2026 and 2027.

From the FDA notice · Read the official notice ↗

What to do

  1. Do not use Vivoo Sodium Test (lot 2024013123), Vitamin C Test (lot 2024013124), or Hydration Test (lots 2024013119 or 2025051519)
  2. Discard the test strips or contact Vivoo for instructions on returns
  3. Do not rely on results from these tests for any health decisions
  4. Consult your doctor if you made medical decisions based on these tests
Official notice ↗

Is yours affected?

Compare your label or packaging with the recalled product.

Product
Vivoo Sodium Test; Vivoo Vitamin C Test; Vivoo Hydration Test
Sold in
Nationwide
Made for
Adults (18 years to 100 years)

This recall covers 11 products — see all of them.

Details

Units affected
3,300
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-1267-2026

In the FDA's words

Description
Vivoo Sodium Test; Vivoo Vitamin C Test; Vivoo Hydration 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): Vivoo Sodium Test/2024013123(01/30/2026); Vivoo Vitamin C Test/2024013124(01/30/2026); Vivoo Hydration Test/2024013119(01/30/2026), 2025051519(05/14/2027) Distribution: US Nationwide distribution in the states of TX, GA, CA. Affected quantity: 3,300
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.

Related topics

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