Changchun Wancheng Bio-Electron Recalls S. Typhi/Para Typhi A Antigen Test Strips Over Marketing Concerns
Changchun Wancheng Bio-Electron Co., Ltd. is recalling 1,000 S. Typhi/Para Typhi A Antigen test strips distributed in the U.S. without required FDA 510(k) clearance.
What Happened
Changchun Wancheng Bio-Electron Co., Ltd. has initiated a voluntary recall of its S. Typhi/Para Typhi A Antigen test strips. The recall was prompted because the devices, which require 510(k) clearance, were distributed to U.S. customers before they could be legally marketed. According to the FDA, these devices may produce false or inaccurate diagnostic results when used by laypersons, which could lead to inappropriate medical interventions.
Which Products Are Affected
The recall involves 1,000 units of the following product:
- Product Name: S. Typhi/Para Typhi A Antigen
- Lot Number: GT-STA 20251601
- Expiration Date: 05-2027
- Recall Number: Z-1261-2026
Distribution was nationwide within the United States, specifically targeting the states of Texas, Georgia, and California.
What You Should Do
Consumers, distributors, and healthcare providers who have the affected test strips should immediately cease their use. The recalling firm initiated the notification process via letter on November 22, 2025. For specific instructions on returning or disposing of the product, contact Changchun Wancheng Bio-Electron Co., Ltd. at their address: 2336, Tianwei Road, Beihu Science and Technology Development Zone, Changchun, China.
Why This Matters
The distribution of medical devices without proper regulatory clearance poses a risk to public health, as the accuracy and safety of the tests have not been verified for the U.S. market. Inaccurate results can lead to delayed treatment or unnecessary medical procedures.
Source
This information is based on an official report from the FDA.
Source: FDA Official Notice