Recall Weekly
Moderate riskFDA DeviceClass II

Vivoo pH test strips recalled for lacking required FDA clearance

Vivoo pH Test strips were sold in the U.S. before receiving required FDA approval. The strips may give false or inaccurate results, which could lead to inappropriate medical decisions based on incorrect findings.

From the FDA notice · Read the official notice ↗

What to do

  1. Stop using your Vivoo pH Test strips immediately
  2. Contact Changchun Wancheng Bio-Electron Co., Ltd. or your retailer for instructions on returning the product
  3. Consult a healthcare provider if you made health decisions based on test results from this product
Official notice ↗

Is yours affected?

Compare your label or packaging with the recalled product.

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

This recall covers 11 products — see all of them.

Details

Units affected
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-1264-2026

In the FDA's words

Description
Vivoo pH 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 pH Test/2024013121(01/30/2026) Distribution: US Nationwide distribution in the states of TX, GA, CA. Affected quantity: 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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