FDA Medical Device Recalls (openFDA)
Changchun Wancheng Bio-Electron Co., Ltd.: Vivoo Vaginal pH Test
- Recall number
- Z-1266-2026
- Recalling firm
- Changchun Wancheng Bio-Electron Co., Ltd.
- Product
- Vivoo Vaginal pH Test
- Status
- Open, Classified
- Initiated
- 2025-11-22
- Posted
- 2026-02-04
- Terminated
- not on file
- Reason
- 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.
- 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: sales04@ccwancheng.com Questions can be emailed to the firm at: sales01@ccwancheng.com / sales04@ccwancheng.com
- Quantity
- 3,000
- Distribution
- US Nationwide distribution in the states of TX, GA, CA.
- Lot, serial or model codes
- Name/Lot(Expiration): Vivoo Vaginal pH Test/2024032219(03/21/2026)
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- LNW
- Firm FEI
- 3008987086
- Firm city
- Changchun
- Firm state
- Beihu
- Firm country
- China
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28