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U.S. Department of Health and Human Services

Class 2 Device Recall Multiple

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 Class 2 Device Recall Multiplesee related information
Date Initiated by FirmNovember 22, 2025
Date PostedFebruary 04, 2026
Recall Status1 Open3, Classified
Recall NumberZ-1258-2026
Recall Event ID 97801
Product Classification Nitroprusside, ketones (urinary, non-quant.) - Product Code JIN
ProductThe Girlfriend Doctor Dr. Anna Cabeca Keto-pH-Uric Acid Test Strips; URIMED Urinalysis Reagent Strips URS-5, Rapid UTI Test Includes Ketones: Leukocytes, Nitrite, pH, Ketone, Protein; Vivoo Ketone Test
Code Information Name/Lot(Expiration): The Girlfriend Doctor Dr. Anna Cabeca Keto-pH-Uric Acid Test Strips/2024032508(03/24/2026), 2024071602(07/15/2026), 2024102108(10/20/2026); URIMED Urinalysis Reagent Strips URS-5, Rapid UTI Test Includes Ketones: Leukocytes, Nitrite, pH, Ketone, Protein/2025043007(04/29/2027); Vivoo Ketone 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 2		No Marketing Application
ActionStarting 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 Commerce32,500
DistributionUS Nationwide distribution in the states of TX, GA, CA.
Total Product Life CycleTPLC 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.
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