medical Class II Updated 2022-04-13

WHPM Inc. recalls First SIGN SARS-CoV-2 Antigen Test

Recalled Product

First SIGN SARS-CoV-2 Antigen Test

Hazard / Issue

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.

Issued by

FDA

Affected States: CA, FL, LA, MA, TX

Lot/Code Info: Model Number: FSSA-CK20 UDI Codes: None Lot Numbers: F0301214078; F1227210039; F0809210004; F0906210010; P0211214070; F0914210014; F1013210020; F1214210034; F0121220041;

View official government recall

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