The 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
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
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customers; devices may cause false or inaccurate diagnostic result by lay person and lead to inappropriate medical intervention.
Recall Number
Z-1258-2026
Classification
Class II
Status
Ongoing
Category
device
Initiated
2025-11-22
Reported
2026-02-11
Distribution
US Nationwide distribution in the states of TX, GA, CA.
Code Info
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)
Source: openFDA enforcement report. WhichRecall is not affiliated with the FDA. See our disclaimer.