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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