Changchun Wancheng Bio-Electron Recalls Vivoo Vaginal pH Tests Due to Lack of Marketing Clearance
Changchun Wancheng Bio-Electron Co., Ltd. is recalling 3,000 Vivoo Vaginal pH Tests because they were distributed without legal marketing clearance, posing a risk of inaccurate results.
What Happened
Changchun Wancheng Bio-Electron Co., Ltd. has issued a voluntary recall for its Vivoo Vaginal pH Test strips. The recall was initiated because the products were distributed to customers in the United States before they could be legally marketed through the required 510(k) clearance process. 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 approximately 3,000 units of the following product:
- Product Name: Vivoo Vaginal pH Test
- Lot Number: 2024032219
- Expiration Date: 03/21/2026
- Recall Number: Z-1266-2026
The affected products were distributed nationwide, specifically within the states of Texas, Georgia, and California.
What You Should Do
Consumers who possess the Vivoo Vaginal pH Test from the affected lot should discontinue use immediately. The recalling firm, Changchun Wancheng Bio-Electron Co., Ltd., initiated the notification process via letter. Consumers should contact the company or their point of purchase for instructions regarding the return or disposal of the product.
Why This Matters
The distribution of medical devices without proper regulatory clearance poses a safety risk, as the accuracy of the results cannot be guaranteed. Inaccurate pH readings may lead consumers to pursue incorrect medical treatments or fail to seek necessary care.
Source
This recall information is sourced from the FDA.
Source: FDA Official Notice