Z-0892-2022 Class II Terminated
FDA device recall Z-0892-2022 was initiated by WHPM Inc. on March 4, 2022 and is designated Class II. 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… The recall status is terminated (terminated February 5, 2025). Affected quantity: 535,755 tests.
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;