FDA Device recall Z-0892-2022
First SIGN SARS-CoV-2 Antigen Test
- FDA Device
- Class II
- terminated
- Published 2022-04-13
On 2022-04-13 the FDA classified a Class II recall of First SIGN SARS-CoV-2 Antigen Test by Whpm, citing 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 re….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0892-2022 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2022-03-04 |
| Published | 2022-04-13 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Whpm |
| Distribution | CA, FL, LA, MA, TX |
Product
First SIGN SARS-CoV-2 Antigen Test
Reason
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.
Identifiers
| code_info | Model Number: FSSA-CK20 UDI Codes: None Lot Numbers: F0301214078; F1227210039; F0809210004; F0906210010; P02112…Model Number: FSSA-CK20 UDI Codes: None Lot Numbers: F0301214078; F1227210039; F0809210004; F0906210010; P0211214070; F0914210014; F1013210020; F1214210034; F0121220041; |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0892-2022%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.