Recall Z-1259-2026
Changchun Wancheng Bio-Electron Co., Ltd. · initiated November 22, 2025
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
LH One Step Ovulation Test Device (Urine)
Codes / lots: Name/Lot(Expiration): LH One Step Ovulation Test Device (Urine)/GT-LH 20251601(05-2027)
Reason for recall
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.
FDA-determined cause: No Marketing Application
Action taken
Starting on 11/22/2025, recall notices were mailed or emailed to customers/distributors who were asked to do the following: 1) Destroy unused devices. 2) Inform customers that test results may be inaccurate, and it is recommended to re-test. 3) If affected devices were further distributed, please forward this notice and response form to these additional customers or email us a customer distribution list with names, emails, addresses, phone numbers so we can notify your customers of the recall. 4) Complete and return the Acknowledgement and Receipt Form via email to: sales04@ccwancheng.com Questions can be emailed to the firm at: sales01@ccwancheng.com / sales04@ccwancheng.com
Details
- Recall number
- Z-1259-2026
- Initiated
- November 22, 2025
- Posted by FDA
- February 4, 2026
- Product code
- NGE – Test, Luteinizing Hormone (Lh), Over The Counter
- Quantity
- 1,000
- Distribution
- US Nationwide distribution in the states of TX, GA, CA.
- Recalling firm
- Changchun Wancheng Bio-Electron Co., Ltd., Changchun, Beihu
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1257-2026 Class II | LotFancy Urinary Tract Infection Urine (UTI) Test Strips; PALINOIA UTI-10 PARAMETER…Test strips and other tests including for near-patient testing, that require a 510(k) were distributed… | 11/22/2025Open, Classified |
| Z-1258-2026 Class II | The Girlfriend Doctor Dr. Anna Cabeca Keto-pH-Uric Acid Test Strips; URIMED Urinalysis…Test strips and other tests including for near-patient testing, that require a 510(k) were distributed… | 11/22/2025Open, Classified |
| Z-1260-2026 Class II | Menopause Test Cassette (Urine)Test strips and other tests including for near-patient testing, that require a 510(k) were distributed… | 11/22/2025Open, Classified |
| Z-1261-2026 Class II | S. Typhi/Para Typhi A AntigenTest strips and other tests including for near-patient testing, that require a 510(k) were distributed… | 11/22/2025Open, Classified |
| Z-1262-2026 Class II | Male Fertility Sperm Test for Home Use (Cassette)Test strips and other tests including for near-patient testing, that require a 510(k) were distributed… | 11/22/2025Open, Classified |
| Z-1263-2026 Class II | Exploro Highly Sensitive Male Fertility / Sperm Concentration TestTest strips and other tests including for near-patient testing, that require a 510(k) were distributed… | 11/22/2025Open, Classified |
| Z-1264-2026 Class II | Vivoo pH TestTest strips and other tests including for near-patient testing, that require a 510(k) were distributed… | 11/22/2025Open, Classified |
| Z-1265-2026 Class II | Vivoo Protein TestTest strips and other tests including for near-patient testing, that require a 510(k) were distributed… | 11/22/2025Open, Classified |
| Z-1266-2026 Class II | Vivoo Vaginal pH TestTest strips and other tests including for near-patient testing, that require a 510(k) were distributed… | 11/22/2025Open, Classified |
| Z-1267-2026 Class II | Vivoo Sodium Test; Vivoo Vitamin C Test; Vivoo Hydration TestTest strips and other tests including for near-patient testing, that require a 510(k) were distributed… | 11/22/2025Open, Classified |