Medical device recalls High risk

SML Distribution, LLC recalls Skippack Medical Lab SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold); COVID 19 Test

Recall date
March 4, 2022
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0944-2022
FDA classification
Class I
Brand / firm
SML Distribution, LLC
Sold / distributed
US Nationwide distribution in the states of AL, FL, GA, MO, NY, TX, and WY.

Why it was recalled

The product was distributed without FDA authorization or clearance for marketing and distribution in the US.

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

Skippack Medical Lab SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold); COVID 19 Test

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