Class IIReported 2026-02-11
Vivoo Protein Test
Recalled by Changchun Wancheng Bio-Electron Co., Ltd.
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
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customers; devices may cause false or inaccurate diagnostic result by lay person and lead to inappropriate medical intervention.