Z-1258-2026Class II
The Girlfriend Doctor Dr. Anna Cabeca Keto-pH-Uric Acid Test Strips; URIMED Urinalysis Reagent Strips URS-5...
Changchun Wancheng Bio-Electron Co., Ltd. / initiated 2025-11-22 / Open, Classified
Changchun Wancheng Bio-Electron Co., Ltd. began a recall of The Girlfriend Doctor Dr. Anna Cabeca Keto-pH-Uric Acid Test Strips; URIMED Urinalysis Reagent Strips URS-5, Rapid UTI Test Includes Ketones: Leukocytes... on . FDA classified it as Class II and gives the reason as "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...". As of , the recall status on record is Open, Classified.
Recall record
- Recall number
- Z-1258-2026
- Classification
- Class II
- Status
- Open, Classified
- Initiated
- Posted
- Recalling firm
- Changchun Wancheng Bio-Electron Co., Ltd.
- 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
- Product code
- JIN Nitroprusside, Ketones (Urinary, Non-Quant.)
- 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 root 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: [email protected] Questions can be emailed to the firm at: [email protected] / [email protected]
- Quantity in commerce
- 32,500
- Distribution
- US Nationwide distribution in the states of TX, GA, CA.
- Product codes and lots
- 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)
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-1257-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1258-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1259-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1260-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1261-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1262-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1263-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1264-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1265-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1266-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1267-2026 | Class II | Ongoing | Voluntary: Firm initiated |
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