FDA-Device2026-02-11Class IIMISBRANDING
Changchun Wancheng Menopause Test Cassette recalled for unreliable results
What this means
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.
- Do not use this test kit if you have it
- Discard lot GT-FSH 20251601 (expiration 05-2027)
- Speak with your doctor about approved menopause tests or other diagnostic options
The agency's original wording
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.
Intended for
Adults
Illnesses reported
None reported
Sold states
US Nationwide distribution in the states of TX, GA, CA.
Affected count
1,000
Manufactured in
2336, Tianwei Road, Beihu Science and Technology Development Zone, Changchun, N/A, China
Products
Menopause Test Cassette (Urine)
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1260-2026Want us to check the next one for you?
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