# FDA recall Z-0892-2022

> **WHPM Inc.** · Class II · device recall initiated 2022-03-04.

## 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.

## Distribution

U.S.: CA, FL, LA, MA and TX    O.U.S.: N/A

## Key facts

- **Recall number:** Z-0892-2022
- **Recalling firm:** WHPM Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2022-03-04
- **Report date:** 2022-04-13
- **Termination date:** 2025-02-05

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Irwindale, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0892-2022

## Citation

> AI Analytics. FDA recall Z-0892-2022. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-0892-2022. Source: US FDA. Licensed CC0.

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