tyrone, PA, United States
SML Distribution, LLC recalls
1 recall recorded since 2018, most recently on 4 March 2022. 1 is listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)1
Terminated or completed0
Class I (FDA)1
Ongoing Class I Medical devices
- Recall started
- 4 March 2022
- Reason
- 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.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0944-2022
- Skippack Medical Lab SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold); COVID 19 Test
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.