Medical DeviceView official recall notice →
Vivoo Sodium Test; Vivoo Vitamin C Test; Vivoo Hydration Test
Brand / Firm
Product
Vivoo Sodium Test; Vivoo Vitamin C Test; Vivoo Hydration 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.
Units affected
3,300
Description
Vivoo Sodium Test; Vivoo Vitamin C Test; Vivoo Hydration Test