Changchun Wancheng Bio-Electron Co. recalled 32,500 Keto-pH-Uric Acid Test Strips on November 22, 2025. The strips may provide inaccurate results and lead to inappropriate medical intervention. The recall affects products distributed nationwide in 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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The recalled products include The Girlfriend Doctor Dr. Anna Cabeca Keto-pH-Uric Acid Test Strips and URIMED Urinalysis Reagent Strips URS-5. The affected lot numbers are 2024032508, 2024071602, 2024102108, and others with expiration dates ranging from January 30, 2026, to April 29, 2027.
These test strips require a 510(k) clearance before marketing in the U.S. They can produce false or inaccurate results when used by laypersons, potentially leading to inappropriate medical decisions.
No specific incidents or injuries have been reported as of the recall date. The potential for misdiagnosis poses significant health risks.
Patients and healthcare providers should stop using the affected test strips immediately. Contact Changchun Wancheng Bio-Electron Co., Ltd. or your healthcare provider for further instructions.
For more information, visit the FDA recall page at https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-1258-2026.
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