URGENT: Voluntary Nationwide Recall of Urine Test Strips<\/p>\n
February 14, 2026<\/p>\n
Changchun Wancheng Bio-Electron Co., Ltd. Issues Voluntary Nationwide Recall of All Urine Test Strips Distributed in the United States<\/strong><\/p>\n Changchun, China<\/strong> \u2013 Changchun Wancheng Bio-Electron Co., Ltd. is voluntarily recalling all lots<\/strong> of Urine Test Strips (including Single-Parameter and Multi-Parameter configurations) distributed to the United States market.<\/p>\n Reason for Recall:<\/strong> These products were distributed without the required FDA 510(k) premarket notification clearance. While some products may have been labeled for “educational” or “wellness” purposes, the US FDA has determined that these devices are regulated medical devices intended for near-patient testing and are not exempt from 510(k) requirements. Consequently, the safety and effectiveness of these devices for Over-The-Counter (OTC) use have not been reviewed by the FDA.<\/p>\n Risk Statement:<\/strong> For products intended for diagnostic or screening use (e.g., Sodium, UTI, Ketone, pH, etc.), there is a potential risk of false results (false positives or false negatives).<\/p>\n Affected Products:<\/strong> This recall covers ALL<\/strong> urine test strips manufactured by Changchun Wancheng and distributed in the US, regardless of the brand name on the box. These products may have been sold under various brand names, including but not limited to:<\/p>\n Action Required:<\/strong><\/p>\n Contact Information:<\/strong> Consumers or distributors with questions regarding this recall may contact Changchun Wancheng Bio-Electron Co., Ltd. at:<\/p>\n This recall is being conducted with the request of the U.S. Food and Drug Administration (FDA).<\/p>\n","protected":false},"excerpt":{"rendered":" URGENT: Voluntary Nationwide Recall of Urine Test Strips February 14, 2026 Changchun Wancheng Bio-Electron Co., Ltd. Issues Voluntary Nationwide Recall…<\/p>\n","protected":false},"author":1,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"spay_email":"","footnotes":""},"class_list":["post-6112","page","type-page","status-publish","hentry"],"yoast_head":"\n\n
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