Wondfo USA Co Ltd recalls Clarity and Clarity Diagnostics LLC, Streptococcal A rapid test kits, Labeled as: a) Clarity Strep A Rapid Test, Part N…

Recall date

April 22, 2024

Source

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

Recall number

Z-2031-2024

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

Clarity and Clarity Diagnostics LLC, Streptococcal A rapid test kits, Labeled as: a) Clarity Strep A Rapid Test, Part Number CD-STP25, b) Clarity Diagnostics LLC, Clarity Strep A Rapid Test, Part Number CD-STP25V