Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Male Fertility Sperm Test for Home Use (Cassette) Recalled by Changchun Wancheng Bio-Electron Co., Ltd. Due to Test strips and other tests including for near-patient...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Changchun Wancheng Bio-Electron Co., Ltd. directly.
Affected Products
Male Fertility Sperm Test for Home Use (Cassette)
Quantity: 1,000
Why Was This Recalled?
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.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Changchun Wancheng Bio-Electron Co., Ltd.
Changchun Wancheng Bio-Electron Co., Ltd. has 11 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report