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Changchun Wancheng Bio-Electron Co., Ltd. recalls Male Fertility Sperm Test for Home Use (Cassette)
Recalled February 11, 2026 · FDA recall Z-1262-2026 · Changchun Wancheng Bio-Electron
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. · FDA Class II
Units
1,000
Sold at
US Nationwide distribution in the states of TX, GA, CA.
Description
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.
Product
Male Fertility Sperm Test for Home Use (Cassette)
Manufacturer(s)
Changchun Wancheng Bio-Electron Co., Ltd.
Made in
China
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →