Medical device recalls High risk

Woodside Acquisitions Inc. recalls Joysbio SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold); COVID 19 Test

Recall date
April 9, 2022
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1045-2022
FDA classification
Class I
Brand / firm
Woodside Acquisitions Inc.
Sold / distributed
US distributions to states of: AL and GA.

Why it was recalled

Firm distributed tests which have not been cleared or authorized for marketing or distribution in the United States.

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

Joysbio SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold); COVID 19 Test

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