---
title: "First SIGN SARS-CoV-2 Antigen Test — FDA record Z-0892-2022 | Is It on Recall"
description: "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 Antige"
url: https://isitonrecall.com/recall/fda-device-z-0892-2022-first-sign-sars-cov-2-antigen-test/
updated: 2026-10-01
site: "Is It on Recall"
language: en
---

[Recall archive](https://isitonrecall.com/archives/) / 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](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/).

## 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

[Open the official record](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0892-2022%22)

[What the recall classes mean](https://isitonrecall.com/guides/recall-classes/). 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.

- [California](https://isitonrecall.com/state/california/)
- [Florida](https://isitonrecall.com/state/florida/)
- [Louisiana](https://isitonrecall.com/state/louisiana/)
- [Massachusetts](https://isitonrecall.com/state/massachusetts/)
- [Texas](https://isitonrecall.com/state/texas/)

## 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.

## What to do next

Read the official notice for the action that applies to your exact product.

[Read the current instructions](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0892-2022%22)

## Related records

[Medical devices records](https://isitonrecall.com/category/medical-devices/) [WHPM Inc. records](https://isitonrecall.com/brand/whpm-inc/)