Recall Weekly
Moderate riskFDA DeviceClass II

Changchun Wancheng menopause test recalled for possible false results

Changchun Wancheng Bio-Electron distributed urine-based menopause test kits (lot GT-FSH 20251601) without required FDA approval. These tests may give false or inaccurate results, potentially leading to unnecessary medical treatment.

From the FDA notice · Read the official notice ↗

What to do

  1. Do not use this test kit if you have it
  2. Discard lot GT-FSH 20251601 (expiration 05-2027)
  3. Speak with your doctor about approved menopause tests or other diagnostic options
Official notice ↗

Is yours affected?

Compare your label or packaging with the recalled product.

Product
Menopause Test Cassette (Urine)
Sold in
Nationwide
Made for
Adults (0 months and older)

This recall covers 11 products — see all of them.

Details

Units affected
1,000
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-1260-2026

In the FDA's words

Description
Menopause Test Cassette (Urine) 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): Menopause Test Cassette (Urine)/GT-FSH 20251601(05-2027) Distribution: US Nationwide distribution in the states of TX, GA, CA. Affected quantity: 1,000
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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