FDA-Device2026-02-11Class II

Exploro Highly Sensitive Male Fertility / Sperm Concentration Test

Changchun Wancheng Bio-Electron Co., Ltd.

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.

Sold states

US Nationwide distribution in the states of TX, GA, CA.

Affected count

4,800

Manufactured in

2336, Tianwei Road, Beihu Science and Technology Development Zone, Changchun, N/A, China

Products

Exploro Highly Sensitive Male Fertility / Sperm Concentration Test

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1263-2026

Original summary

Exploro Highly Sensitive Male Fertility / Sperm Concentration Test 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. Name/Lot(Expiration): Exploro Highly Sensitive Male Fertility / Sperm Concentration Test/2025033101(03-30-2027), 2025080801(08-07-2027), 2025090844(09-07-2027) Distribution: US Nationwide distribution in the states of TX, GA, CA. Affected quantity: 4,800

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