Recall Weekly
Moderate riskFDA DeviceClass II

Vivoo Protein Test strips recalled for possible inaccurate results

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

From the FDA notice · Read the official notice ↗

What to do

  1. Stop using your Vivoo Protein Test strips immediately
  2. Do not rely on results from lot 2024013122
  3. Contact your healthcare provider if you used this test and made health decisions based on the results
  4. Contact Changchun Wancheng Bio-Electron Co., Ltd. for instructions on returning the product
Official notice ↗

Is yours affected?

Compare your label or packaging with the recalled product.

Product
Vivoo Protein Test
Sold in
Nationwide
Made for
Adults (0 months and older)

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-1265-2026

In the FDA's words

Description
Vivoo Protein 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 Protein Test/2024013122(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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