Recall archive / FDA device enforcement
First SIGN SARS-CoV-2 Antigen Test — FDA record Z-0892-2022
Reported terminated
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Mar 4, 2022. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- 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.
- Classification
- Class II
- Recalling firm
- WHPM Inc.
- Quantity
- 535,755 tests
- Agency-reported status
- Terminated
- Source record identifier
- Z-0892-2022
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | Model Number: FSSA-CK20 UDI Codes: None Lot Numbers: F0301214078; F1227210039; F0809210004; F0906210010; P0211214070; F0914210014; F1013210020; F1214210034; F0121220041; |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
U.S.: CA, FL, LA, MA and TX O.U.S.: N/A
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
Dates in the source
- Report date
- Apr 13, 2022
- Recall initiation date
- Mar 4, 2022
- Center classification date
- Apr 7, 2022
- Termination date
- Feb 5, 2025
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.