Grapevine, TX, United States
USA Medical, LLC recalls
1 recall recorded since 2018, most recently on 4 April 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)0
Ongoing Class II Medical devices
- Recall started
- 4 April 2022
- Reason
- COVID-19/SARS-CoV-2 Antigen Tests did not receive FDA Emergency Use Authorization, nor were the tests cleared or approved to be commercially distributed.
- Distribution
- U.S. Nationwide distribution in the states of CA, FL, IN, MD, MO, NJ, OK, and TN.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1050-2022
- Diagnostic Kit SARS-cCo V Antigen Rapid 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.