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
F0301214078F1227210039F0809210004F0906210010P0211214070F0914210014F1013210020F1214210034F0121220041
- 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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