FDA recall Z-0892-2022

Product

First SIGN SARS-CoV-2 Antigen Test

Reason for recall

Frm became aware that a customer complaint was reported to US FDA that SARS-CoV-2 Antigen Tests were sold domestically by a pharmacy in California. These Antigen Tests have not received FDA Emergency Use Authorization, nor have these tests been cleared or approved by FDA for commercial distribution in the U.S.

Distribution

U.S.: CA, FL, LA, MA and TX O.U.S.: N/A

Key facts

Status

Terminated

Initiation date

2022-03-04

Report date

2022-04-13

Termination date

2025-02-05

Voluntary/Mandated

Voluntary: Firm initiated

Location

Irwindale, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0892-2022