FDA recall Z-0944-2022

SML Distribution, LLC · Class I · device

Product

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

Reason for recall

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

Distribution

US Nationwide distribution in the states of AL, FL, GA, MO, NY, TX, and WY.

Key facts

Status
Ongoing
Initiation date
2022-03-04
Report date
2022-05-11
Voluntary/Mandated
Voluntary: Firm initiated
Location
tyrone, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0944-2022