Class 2 Device Recall Vivoo Protein Test

• Date Initiated by Firm: November 22, 2025
• Date Posted: February 04, 2026
• Recall Status: Open, Classified
• Recall Number: Z-1265-2026
• Recall Event ID: 97801
• Product Classification: Indicator method, protein or albumin (urinary, non-quant.) - Product Code JIR
• Product: Vivoo Protein Test
• Code Information: Name/Lot(Expiration): Vivoo Protein Test/2024013122(01/30/2026)
• Recalling Firm/ Manufacturer: Changchun Wancheng Bio-Electron Co., Ltd.; 2336, Tianwei Road; Beihu Science and Technology Development Zone; Changchun China
• Manufacturer 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.
• FDA Determined 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 in Commerce: 500
• Distribution: US Nationwide distribution in the states of TX, GA, CA.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.