FDA-Device2022-04-13Class II
First SIGN SARS-CoV-2 Antigen Test
WHPM Inc.
Hazard
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.
Sold states
U.S.: CA, FL, LA, MA and TX O.U.S.: N/A
Affected count
535,755 tests
Manufactured in
5358 Irwindale Ave Ste B, Irwindale, CA, United States
Products
First SIGN SARS-CoV-2 Antigen Test
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0892-2022Don't want to check this manually?
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