Vivoo Protein Test
Reported: February 11, 2026 Initiated: November 22, 2025 #Z-1265-2026
Product Description
Vivoo Protein Test
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.
Details
- Recalling Firm
- Changchun Wancheng Bio-Electron Co., Ltd.
- Units Affected
- 500
- Distribution
- US Nationwide distribution in the states of TX, GA, CA.
- Location
- Changchun, N/A
Frequently Asked Questions
What product was recalled? ▼
Vivoo Protein Test. Recalled by Changchun Wancheng Bio-Electron Co., Ltd.. Units affected: 500.
Why was this product 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 agency issued this recall? ▼
This recall was issued by the FDA Devices on February 11, 2026. Severity: Moderate. Recall number: Z-1265-2026.
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