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

Recall date

March 4, 2022

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0892-2022

FDA classification

Class II

Brand / firm

WHPM Inc.

Sold / distributed

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

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

First SIGN SARS-CoV-2 Antigen Test