FDA Device recall Z-1258-2026

The Girlfriend Doctor Dr. Anna Cabeca Keto-pH-Uric Acid Test Strips

• FDA Device
• Class II
• ongoing
• Published 2026-02-11

On 2026-02-11 the FDA classified a Class II recall of The Girlfriend Doctor Dr. Anna Cabeca Keto-pH-Uric Acid Test Strips by Changchun Wancheng Bio Electron, citing 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 f….

Read the official FDA Device notice

Product

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

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.

Identifiers

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:58 UTC. Current status: ongoing.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1258-2026%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.