Vivoo pH Test
FDA Recall Z-1264-2026 · Posted 2026-02-04
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Recalling FirmChangchun Wancheng Bio-Electron Co., Ltd.
Recall StatusOpen, Classified
Product CodeCEN
Date Initiated2025-11-22
Product Quantity500
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.
Firm 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: [email protected]
Questions can be emailed to the firm at: [email protected] / [email protected]
Root Cause
No Marketing Application
Distribution Pattern
US Nationwide distribution in the states of TX, GA, CA.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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