First SIGN SARS-CoV-2 Antigen Test — Class II medical device recall Z-0892-2022
Terminated recall by WHPM Inc., reported 2022-04-13, distributed in CA, FL, LA, MA, TX. Frm became aware that a customer complaint was reported to US FDA that SARS-CoV-2 Antigen Tests were sold dome
| Recall number | Z-0892-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | WHPM Inc., Irwindale, CA, United States |
| Recall initiated | 2022-03-04 |
| Classified | 2022-04-07 |
| Reported by FDA | 2022-04-13 |
| Terminated | 2025-02-05 |
| Distributed | CA, FL, LA, MA, TX |
| Quantity | 535,755 tests |
| Lot numbers | F0121220041, F0301214078, F0809210004, F0906210010, F0914210014, F1013210020, F1214210034, F1227210039, P0211214070 |
| Model numbers | FSSA-CK20 |
Product
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0892-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.