Class II

Medical Device Recall: Preview Strep A, Streptococcal A rapid test kits, Part Numbers: a) PRE-STA-25, b) PRE-STA-A-10

Wondfo USA Co Ltd · April 22, 2024

Reason for Recall

Wondfo USA has identified unauthorized distribution of the Preview Strep A Test Kit. Unauthorized distribution of this device would include sales and distribution of this test for at-home use, non-prescription use, over-the-counter use, or direct-to-consumer customers.

Distribution

US Nationwide distribution.

States Affected

NATIONWIDE

Quantity Affected

1,238,755 units

Source: FDA (openFDA Device Enforcement)

Recall number: Z-2030-2024

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.