Changchun Wancheng Bio-Electron Co. recalled 4,800 Exploro Male Fertility Tests on November 22, 2025. These devices may provide false diagnostic results, potentially leading to inappropriate medical interventions. Consumers should stop using the product immediately and follow recall instructions.
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 Exploro Highly Sensitive Male Fertility / Sperm Concentration Test is designed to help men assess their sperm concentration levels. Consumers typically buy this product to evaluate their fertility potential at home, offering privacy and convenience.
The tests may provide false results due to distribution without proper regulatory clearance, which can mislead users in making health decisions. This can lead to unnecessary anxiety or incorrect medical interventions.
This recall is not part of a broader industry pattern.
Consumers may face delays in obtaining accurate fertility assessments, which can affect their family planning decisions. The potential for misdiagnosis adds urgency to the recall.
You can find the lot number and expiration date on the test box or the insert included with the product.
Expect to receive your refund within 4-6 weeks after submitting the return.
Keep a record of your purchase receipt, any correspondence with the manufacturer, and photos of the product for your records.
The recalled product is the Exploro Highly Sensitive Male Fertility / Sperm Concentration Test. The affected lot numbers include 2025033101, 2025080801, and 2025090844, with expiration dates ranging from March 30, 2027, to September 7, 2027. The tests were distributed nationwide in Texas, Georgia, and California.
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