Changchun Wancheng Bio-Electron Co., Ltd. device recall (Cls II)

Male Fertility Sperm Test for Home Use (Cassette) — Reason: 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. — Status: Ongoing