Wondfo USA Co Ltd recalls Streptococcal A rapid test kits, labeled as: Easy Healthcare Corporation, Areta Strep A Swab Test and EASY at Home Medi…

Recall date

April 22, 2024

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2032-2024

FDA classification

Class II

Brand / firm

Wondfo USA Co Ltd

Sold / distributed

US Nationwide distribution.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Streptococcal A rapid test kits, labeled as: Easy Healthcare Corporation, Areta Strep A Swab Test and EASY at Home Medical LLC, Areta One Step Strep A Swab Test, Part Number ARST-100