WhichRecall
Class IIReported 2026-02-11

Exploro Highly Sensitive Male Fertility / Sperm Concentration Test

Recalled by Changchun Wancheng Bio-Electron Co., Ltd.

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

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customers; devices may cause false or inaccurate diagnostic result by lay person and lead to inappropriate medical intervention.

Recall Number
Z-1263-2026
Classification
Class II
Status
Ongoing
Category
device
Initiated
2025-11-22
Reported
2026-02-11
Distribution
US Nationwide distribution in the states of TX, GA, CA.
Code Info
Name/Lot(Expiration): Exploro Highly Sensitive Male Fertility / Sperm Concentration Test/2025033101(03-30-2027), 2025080801(08-07-2027), 2025090844(09-07-2027)
Source: openFDA enforcement report. WhichRecall is not affiliated with the FDA. See our disclaimer.
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