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Medical Device

Male Fertility Sperm Test for Home Use (Cassette)

Recall date: 2026-02-11 · Source: FDA_DEVICE
Brand / Firm
Changchun Wancheng Bio-Electron Co., Ltd.
Product
Male Fertility Sperm Test for Home Use (Cassette)
Reason for recall
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.
Units affected
1,000
Description
Male Fertility Sperm Test for Home Use (Cassette)
View official recall notice →