Changchun Wancheng Bio-Electron Recalls LH One Step Ovulation Test Devices Over Lack of FDA Clearance

What Happened

Changchun Wancheng Bio-Electron Co., Ltd. has initiated a voluntary recall of its LH One Step Ovulation Test Device (Urine). The recall was prompted because the devices were distributed to U.S. customers before they received the required 510(k) clearance to be legally marketed. According to the FDA, these devices may produce false or inaccurate diagnostic results when used by a layperson, which could lead to inappropriate medical interventions.

Which Products Are Affected

The recall involves 1,000 units of the following product:

• Product Name: LH One Step Ovulation Test Device (Urine)
• Lot Number: GT-LH 20251601
• Expiration Date: 05-2027
• Recall Number: Z-1259-2026

The affected products were distributed nationwide in the United States, with specific distribution identified in Texas (TX), Georgia (GA), and California (CA).

What You Should Do

Consumers who possess the affected test devices should stop using them immediately. The recalling firm initiated notification to customers via letter. For instructions on returns or to address concerns regarding previously used tests, consumers should contact Changchun Wancheng Bio-Electron Co., Ltd. directly.

Why This Matters

This recall is classified as Class II, indicating that the use of the product may cause temporary or medically reversible adverse health consequences. Inaccurate results from an ovulation test can lead to incorrect health assumptions and unnecessary or improper medical follow-up.

Source

Information provided by the FDA.