Reported Apr 13, 2022 · Terminated

First SIGN SARS-CoV-2 Antigen Test

WHPM Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: WHPM Inc. · 5358 Irwindale Ave Ste B · Irwindale, CA · 91706-2086

Is this the product you have?

  • First SIGN SARS-CoV-2 Antigen Test
Lot codes and dates
  • Model NumberFSSA-CK20
  • UDI CodesNone
  • Lot Numbers
    • F0301214078
    • F1227210039
    • F0809210004
    • F0906210010
    • P0211214070
    • F0914210014
    • F1013210020
    • F1214210034
    • F0121220041
Amount recalled
535,755 tests

Where it was sold

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.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Feb 5, 2025 · Data as of Sep 19, 6:17 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.