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Changchun Wancheng Bio-Electron Co., Ltd. FDA Recalls

11 recalls on file across devices, 0 of them Class I and 11 still open. This firm is not matched to a listed company.

Newest first

Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.

Product	Reason	Class	Initiated
Male Fertility Sperm Test for Home Use (Cassette)Class IINov 22, 2025Test strips and other tests including for near-patient testi	Test strips and other tests including for near-patient testing, that require a 510(k) were distributed before	Class IIDevices	Nov 22, 2025
The Girlfriend Doctor Dr. Anna Cabeca Keto-pH-Uric Acid Test Strips; URIMED Urinalysis Reagent Strips URS-5, Rapid UTI Class IINov 22, 2025Test strips and other tests including for near-patient testi	Test strips and other tests including for near-patient testing, that require a 510(k) were distributed before	Class IIDevices	Nov 22, 2025
Vivoo Sodium Test; Vivoo Vitamin C Test; Vivoo Hydration TestClass IINov 22, 2025Test strips and other tests including for near-patient testi	Test strips and other tests including for near-patient testing, that require a 510(k) were distributed before	Class IIDevices	Nov 22, 2025
S. Typhi/Para Typhi A AntigenClass IINov 22, 2025Test strips and other tests including for near-patient testi	Test strips and other tests including for near-patient testing, that require a 510(k) were distributed before	Class IIDevices	Nov 22, 2025
Exploro Highly Sensitive Male Fertility / Sperm Concentration TestClass IINov 22, 2025Test strips and other tests including for near-patient testi	Test strips and other tests including for near-patient testing, that require a 510(k) were distributed before	Class IIDevices	Nov 22, 2025
Vivoo Vaginal pH TestClass IINov 22, 2025Test strips and other tests including for near-patient testi	Test strips and other tests including for near-patient testing, that require a 510(k) were distributed before	Class IIDevices	Nov 22, 2025
Vivoo Protein TestClass IINov 22, 2025Test strips and other tests including for near-patient testi	Test strips and other tests including for near-patient testing, that require a 510(k) were distributed before	Class IIDevices	Nov 22, 2025
LotFancy Urinary Tract Infection Urine (UTI) Test Strips; PALINOIA UTI-10 PARAMETER REAGENT STRIPS; Vaunn Medical 8-inClass IINov 22, 2025Test strips and other tests including for near-patient testi	Test strips and other tests including for near-patient testing, that require a 510(k) were distributed before	Class IIDevices	Nov 22, 2025
Menopause Test Cassette (Urine)Class IINov 22, 2025Test strips and other tests including for near-patient testi	Test strips and other tests including for near-patient testing, that require a 510(k) were distributed before	Class IIDevices	Nov 22, 2025
Vivoo pH TestClass IINov 22, 2025Test strips and other tests including for near-patient testi	Test strips and other tests including for near-patient testing, that require a 510(k) were distributed before	Class IIDevices	Nov 22, 2025
LH One Step Ovulation Test Device (Urine)Class IINov 22, 2025Test strips and other tests including for near-patient testi	Test strips and other tests including for near-patient testing, that require a 510(k) were distributed before	Class IIDevices	Nov 22, 2025

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