CLASS II ONGOING Device recall · Reported 11 Feb 2026 · FDA Enforcement Report
The Girlfriend Doctor Dr. Anna Cabeca Keto-pH-Uric Acid Test Strips recalled
Changchun Wancheng Bio-Electron is recalling The Girlfriend Doctor Dr. Anna Cabeca Keto-pH-Uric Acid Test Strips, distributed nationwide in the US. The recall was initiated on 22 Nov 2025 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1258-2026
- FDA event ID
- 97801
- Recalling firm
- Changchun Wancheng Bio-Electron, Changchun, N/A
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 22 Nov 2025
- FDA classified
- 4 Feb 2026
- Reported
- 11 Feb 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Labeling Errors
- Device type
- Insulin Pumps & Glucose Monitors
Timeline
| 22 Nov 2025 | Recall initiated by company | |
| 4 Feb 2026 | Classified by FDA | +74 days |
| 11 Feb 2026 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
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
Where it was distributed
US Nationwide distribution in the states of TX, GA, CA.
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
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)
Where was it sold?
US Nationwide distribution in the states of TX, GA, CA.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
10 other products · FDA event 97801This product is part of a recall event; the main page for the event is Male Fertility Sperm Test for Home Use (Cassette) recalled.
More recalls from Changchun Wancheng Bio-Electron
All 11| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Vivoo Vaginal pH Test recalled by Changchun Wancheng | Changchun Wancheng Bio-Electron | Labeling Errors | Nationwide |
| Device | CLASS II | Menopause Test Cassette (Urine) recalled by Changchun Wancheng | Changchun Wancheng Bio-Electron | Labeling Errors | Nationwide |
| Device | CLASS II | LH One Step Ovulation Test Device (Urine) recalled by Changchun Wancheng | Changchun Wancheng Bio-Electron | Labeling Errors | Nationwide |
| Device | CLASS II | Vivoo Sodium Test recalled by Changchun Wancheng | Changchun Wancheng Bio-Electron | Labeling Errors | Nationwide |
| Device | CLASS II | Vivoo pH Test recalled by Changchun Wancheng | Changchun Wancheng Bio-Electron | Labeling Errors | Nationwide |
Other Insulin Pumps & Glucose Monitors recalls
All 467| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | MiniMed Flex Insulin Pump recalled by Medtronic MiniMed | Medtronic MiniMed | Labeling Errors | Nationwide |
| Device | CLASS II | Fisher Scientific Sure-Vue Urine hCG Strip recalled by Alere San Diego | Alere San Diego | Potency & Assay | Nationwide |
| Device | ANNOUNCED | StatStrip Glucose Hospital Meter System recalled by Nova BiomedicalNova Biomedical StatStrip | Nova Biomedical | Device Malfunction | |
| Device | CLASS I | StatStrip Glucose Hospital Meter System recalled by Nova Biomedical | Nova Biomedical | Device Malfunction | Nationwide |
| Device | CLASS I | StatStrip Glucose and B- Ketone meter recalled by Nova Biomedical | Nova Biomedical | Device Malfunction | Nationwide |