Recall Z-1259-2026 ยท NGE Test, Luteinizing Hormone (Lh), Over The Counter
Changchun Wancheng Bio-Electron Co., Ltd.
LH One Step Ovulation Test Device (Urine)
| Date | Feb 4, 2026 (initiated Nov 22, 2025) |
| Status | Open, Classified |
| Reason | 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. |
| Root cause | No Marketing Application |
| Action | 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 Que |
| Quantity | 1,000 |
| Distribution | US Nationwide distribution in the states of TX, GA, CA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.