Changchun Wancheng Bio-Electron Co., Ltd. recalls Male Fertility Sperm Test for Home Use (Cassette)
Recalled Product
Male Fertility Sperm Test for Home Use (Cassette)
Hazard / Issue
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.
Issued by
FDA
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