Changchun Wancheng Bio-Electron Co. recalled 1,000 male fertility sperm tests on November 22, 2025. The tests were distributed without proper FDA clearance and may yield inaccurate results. This could lead to inappropriate medical interventions by users.
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.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Changchun Wancheng Bio-Electron Co., Ltd. or your healthcare provider for instructions. Notification method: Letter
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The Male Fertility Sperm Test for Home Use is designed for individuals seeking to assess their fertility levels conveniently at home. Consumers typically purchase this product to gain insights into their reproductive health without the need for professional testing.
The hazard arises from the device being distributed without the necessary FDA clearance, leading to the potential for inaccurate results. Users may misinterpret these results, prompting inappropriate medical decisions.
This recall is not part of a broader industry pattern.
Consumers may face significant implications from using inaccurate test results, potentially impacting their health decisions and leading to unnecessary stress.
The model number and expiration date can typically be found on the product packaging or instruction manual.
Expect up to 4-6 weeks for refund processing once the manufacturer receives the product back.
Keep copies of any letters from the manufacturer and your correspondence regarding the recall.
The recalled product is the Male Fertility Sperm Test for Home Use (Cassette), model GT-SPA 20251601 with an expiration date of May 2027. It was distributed nationwide in Texas, Georgia, and California.
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