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WHPM Inc. recalls First SIGN SARS-CoV-2 Antigen Test
Recalled April 13, 2022 · FDA recall Z-0892-2022 · WHPM
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. · FDA Class II
Units
535,755 tests
Sold at
U.S.: CA, FL, LA, MA and TX O.U.S.: N/A
Description
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.
Product
First SIGN SARS-CoV-2 Antigen Test
Manufacturer(s)
WHPM Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →