FDAFDA · Food and drugs·Recall number Z-0892-2022
First SIGN SARS-CoV-2 Antigen Test
Published April 13, 2022 · Recall initiated: March 4, 2022
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- WHPM Inc.
- Distributor
- U.S.: CA, FL, LA, MA and TX O.U.S.: N/A
- Lot
- Model Number: FSSA-CK20 UDI Codes: None Lot Numbers: F0301214078; F1227210039; F0809210004; F0906210010; P0211214070; F0914210014; F1013210020; F1214210034; F0121220041;
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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