Home / Recalls / WHPM Inc. / Z-0892-2022

Z-0892-2022 Class II Terminated

Recalled by WHPM Inc. — Irwindale, CA

Recall Details

Product Type: Devices
Report Date: April 13, 2022
Initiation Date: March 4, 2022
Termination Date: February 5, 2025
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 535,755 tests

Product Description

First SIGN SARS-CoV-2 Antigen Test

Reason for Recall

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.

Distribution Pattern

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

Code Information

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