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Medical Device

Exploro Highly Sensitive Male Fertility / Sperm Concentration Test

Recall date: 2026-02-11 · Source: FDA_DEVICE
Brand / Firm
Changchun Wancheng Bio-Electron Co., Ltd.
Product
Exploro Highly Sensitive Male Fertility / Sperm Concentration Test
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
4,800
Description
Exploro Highly Sensitive Male Fertility / Sperm Concentration Test
View official recall notice →