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Changchun Wancheng Bio-Electron Recalls
11 recalls on record · February 11, 2026 to February 11, 2026 · Medical Devices
February 11, 2026Medical DevicesFDA
Changchun Wancheng Bio-Electron Co., Ltd. recalls Vivoo Sodium Test; Vivoo Vitamin C Test; Vivoo Hydration Test
Hazard: 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.
February 11, 2026Medical DevicesFDA
Changchun Wancheng Bio-Electron Co., Ltd. recalls Vivoo Vaginal pH Test
Hazard: 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.
February 11, 2026Medical DevicesFDA
Changchun Wancheng Bio-Electron Co., Ltd. recalls Vivoo Protein Test
Hazard: 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.
February 11, 2026Medical DevicesFDA
Changchun Wancheng Bio-Electron Co., Ltd. recalls Vivoo pH Test
Hazard: 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.
February 11, 2026Medical DevicesFDA
Changchun Wancheng Bio-Electron Co., Ltd. recalls Exploro Highly Sensitive Male Fertility / Sperm Concentration Test
Hazard: 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.
February 11, 2026Medical DevicesFDA
Changchun Wancheng Bio-Electron Co., Ltd. recalls Male Fertility Sperm Test for Home Use (Cassette)
Hazard: 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.
February 11, 2026Medical DevicesFDA
Changchun Wancheng Bio-Electron Co., Ltd. recalls S. Typhi/Para Typhi A Antigen
Hazard: 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.
February 11, 2026Medical DevicesFDA
Changchun Wancheng Bio-Electron Co., Ltd. recalls Menopause Test Cassette (Urine)
Hazard: 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.
February 11, 2026Medical DevicesFDA
Changchun Wancheng Bio-Electron Co., Ltd. recalls LH One Step Ovulation Test Device (Urine)
Hazard: 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.
February 11, 2026Medical DevicesFDA
Changchun Wancheng Bio-Electron Co., Ltd. recalls The Girlfriend Doctor Dr. Anna Cabeca Keto-pH-Uric Acid Test Strips; URIMED Urinalysis Reagent Strips URS-5, Rapid UTI
Hazard: 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.
February 11, 2026Medical DevicesFDA
Changchun Wancheng Bio-Electron Co., Ltd. recalls LotFancy Urinary Tract Infection Urine (UTI) Test Strips; PALINOIA UTI-10 PARAMETER REAGENT STRIPS; Vaunn Medical 8-in
Hazard: 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.