Z-1260-2026 Class II Ongoing
FDA device recall Z-1260-2026 was initiated by Changchun Wancheng Bio-Electron Co., Ltd. on November 22, 2025 and is designated Class II. 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 di… The recall status is ongoing. Affected quantity: 1,000.
Recall Details
- Product Type
- Devices
- Report Date
- February 11, 2026
- Initiation Date
- November 22, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1,000
Product Description
Menopause Test Cassette (Urine)
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.
Distribution Pattern
US Nationwide distribution in the states of TX, GA, CA.
Code Information
Name/Lot(Expiration): Menopause Test Cassette (Urine)/GT-FSH 20251601(05-2027)