Z-1259-2026Class II

LH One Step Ovulation Test Device (Urine)

Name: Z-1259-2026 LH One Step Ovulation Test Device (Urine)
Creator: Changchun Wancheng Bio-Electron Co., Ltd.
Published: 2025-11-22
License: https://open.fda.gov/license/

Changchun Wancheng Bio-Electron Co., Ltd. / initiated 2025-11-22 / Open, Classified

FDA source

Changchun Wancheng Bio-Electron Co., Ltd. began a recall of LH One Step Ovulation Test Device (Urine) on 2025-11-22. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-1259-2026
Classification: Class II
Status: Open, Classified
Initiated: 2025-11-22
Posted: 2026-02-04
Recalling firm: Changchun Wancheng Bio-Electron Co., Ltd.
Product: LH One Step Ovulation Test Device (Urine)
Product code: NGE Test, Luteinizing Hormone (Lh), Over The Counter
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 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: [email protected] Questions can be emailed to the firm at: [email protected] / [email protected]
Quantity in commerce: 1,000
Distribution: US Nationwide distribution in the states of TX, GA, CA.
Product codes and lots: Name/Lot(Expiration): LH One Step Ovulation Test Device (Urine)/GT-LH 20251601(05-2027)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1259-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1257-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-02-11	2026-02-04
Z-1258-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-02-11	2026-02-04
Z-1259-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-02-11	2026-02-04
Z-1260-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-02-11	2026-02-04
Z-1261-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-02-11	2026-02-04
Z-1262-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-02-11	2026-02-04
Z-1263-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-02-11	2026-02-04
Z-1264-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-02-11	2026-02-04
Z-1265-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-02-11	2026-02-04
Z-1266-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-02-11	2026-02-04
Z-1267-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-02-11	2026-02-04

Product code NGE

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)