FDA-Device2026-02-11Class II
LH One Step Ovulation Test Device (Urine)
Changchun Wancheng Bio-Electron Co., Ltd.
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.
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-1259-2026Original summary
LH One Step Ovulation Test Device (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): LH One Step Ovulation Test Device (Urine)/GT-LH 20251601(05-2027) Distribution: US Nationwide distribution in the states of TX, GA, CA. Affected quantity: 1,000
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