FDA-Device2026-02-11Class IIMISBRANDING
LH One Step Ovulation Test Device recalled for inaccurate results
What this means
Changchun Wancheng Bio-Electron distributed LH One Step Ovulation Test strips in the U.S. without required FDA approval. The tests may give false or inaccurate results, which could lead to wrong medical decisions.
- Stop using LH One Step Ovulation Test strips with lot GT-LH 20251601 (expiration 05-2027)
- Do not rely on results from this test to make medical decisions
- Contact your doctor if you used this test and need guidance on next steps
- Dispose of the test strips safely
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
LH One Step Ovulation Test Device (Urine)
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1259-2026Want us to check the next one for you?
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