LotFancy recalled 91,366 urinary tract infection test strips on November 22, 2025. The strips may produce false results, risking inappropriate medical intervention. Affected products include various models sold nationwide in states like Texas, Georgia, and California.
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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Urinalysis test strips are commonly used to detect urinary tract infections and other health issues through urine samples. Consumers purchase these strips for convenient at-home testing and to avoid unnecessary doctor visits.
The recalled test strips may produce false or inaccurate diagnostic results due to lack of proper FDA clearance. This can lead to misdiagnosis and inappropriate treatment, posing a significant health risk.
This recall is not part of a broader industry pattern.
Consumers using these test strips may inadvertently misdiagnose a UTI or other medical condition, potentially leading to inappropriate medical treatments and further health complications.
Model numbers and expiration dates are typically located on the packaging or on the individual test strip containers.
Expect a refund or replacement process to take approximately 4-6 weeks after contacting the manufacturer.
Keep a record of your purchase receipt, any correspondence with the manufacturer, and photographs of the product as evidence.
The recall affects 91,366 units of urinalysis test strips, including LotFancy Urinary Tract Infection Test Strips and others from brands like PALINOIA, Vaunn Medical, and JNW Direct. These products were distributed across the U.S., particularly in Texas, Georgia, and California. Models include LotFancy UTIs with expiration dates ranging from June 2026 to September 2027.
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