FDA recall Z-1050-2022

Product

Diagnostic Kit SARS-cCo V Antigen Rapid Test

Reason for recall

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.

Key facts

Status

Ongoing

Initiation date

2022-04-04

Report date

2022-05-18

Voluntary/Mandated

Voluntary: Firm initiated

Location

Grapevine, TX, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1050-2022