Changchun Wancheng Bio-Electron Recalls 32,500 Test Strips Over Marketing and Accuracy Concerns
Areazine synthesizes this FDA recall directly from FDA's official public data feed. See our methodology for full source attribution and refresh cadence.
Changchun Wancheng Bio-Electron Co., Ltd. has recalled over 32,000 test strips, including Keto-pH and UTI tests, because they were distributed without legal marketing clearance and may provide inaccurate results.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on April 6, 2026 and geographically references United States. Its severity classification of "high" signals how the issuing agency weighs the risk of harm if no action is taken - "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.
Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.
Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, fda, medical-devices.
What Happened
Changchun Wancheng Bio-Electron Co., Ltd. has initiated a voluntary recall of several diagnostic test strip products. According to the FDA, these devices were distributed before they could be legally marketed to U.S. customers (lacking the required 510(k) clearance). There is a concern that these devices may produce false or inaccurate diagnostic results when used by consumers, which could lead to inappropriate or unnecessary medical interventions.
Which Products Are Affected
A total of 32,500 units are included in this recall. The affected products were distributed nationwide, with specific distribution noted in Texas, Georgia, and California. The recall includes the following brands and lot numbers:
- The Girlfriend Doctor Dr. Anna Cabeca Keto-pH-Uric Acid Test Strips:
- Lot 2024032508 (Expiration: 03/24/2026)
- Lot 2024071602 (Expiration: 07/15/2026)
- Lot 2024102108 (Expiration: 10/20/2026)
- URIMED Urinalysis Reagent Strips URS-5 (Rapid UTI Test Includes Ketones: Leukocytes, Nitrite, pH, Ketone, Protein):
- Lot 2025043007 (Expiration: 04/29/2027)
- Vivoo Ketone Test:
- Lot 2024013122 (Expiration: 01/30/2026)
What You Should Do
Consumers should immediately stop using the affected test strips. The firm initiated the recall notification via letter on November 22, 2025. If you possess any of the products listed above, you should contact the recalling firm, Changchun Wancheng Bio-Electron Co., Ltd., or the retailer where the product was purchased for instructions on returns or disposal. If you have used these strips and are concerned about your health results, consult a healthcare professional.
Why This Matters
Inaccurate diagnostic results from home-use test kits can lead to incorrect self-diagnosis and potentially dangerous medical decisions. Ensuring that medical devices meet FDA marketing standards is critical for maintaining patient safety and diagnostic reliability.
Source
Recall Number: Z-1258-2026. Information provided by the FDA.
Original source: FDA Official Notice ↗
Related FDA Recalls
All FDA Recalls →Frequently Asked Questions
Common questions about this FDA recall.