# FDA recall Z-1432-2021

> **AZURE BIOTECH INC** · Class II · device recall initiated 2021-03-02.

## Product

Assure COVID-19 IgG/IgM Rapid Test Device  that include:  1) Pouch Label - FaStep Rapid Diagnostic Test *** Rapid  Reliable  Simple *** COVID-19 IgG/IgM Rapid Test Device (Whole blood/Serum/Plasma) *** For Emergency Use Authorization Only,  Box Label - FaStep Rapid Diagnostic Test *** COVID-19 IgG/IgM Rapid Test Device (Whole blood/Serum/Plasma) *** For Emergency Use Authorization Only *** For in vitro diagnostic use only,  and     2) Pouch Label - ECOTEST RAPID DIAGNOSTIC TEST *** /Rapid / Reliable / Simple/ *** COVID-19 IgG/IgM Rapid Test Device (Whole blood/Serum/Plasma) *** For Emergency Use Authorization Only,  Box Label - ECOTEST RAPID DIAGNOSTIC TEST *** Rapid  Reliable  Simple *** COVID-19 IgG/IgM Rapid Test Device *** For Professional in vitro diagnostic use only *** For Emergency Use Authorization Only.

## Reason for recall

Due to Products being incorrect labeling "for diagnostic use" and labelled with an unsupported 24 month expiration dating.

## Distribution

Worldwide distribution - U.S. Nationwide distribution in the states of CA. FL, GA, IL, LA, MD, MN, NC, TX, UT, VA and WA. The country of Canada.

## Key facts

- **Recall number:** Z-1432-2021
- **Recalling firm:** AZURE BIOTECH INC
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2021-03-02
- **Report date:** 2021-04-28
- **Termination date:** 2023-03-31

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Houston, TX, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1432-2021

## Citation

> AI Analytics. FDA recall Z-1432-2021. Retrieved 2026-07-03 from https://api.ai-analytics.org/recall/Z-1432-2021. Source: US FDA. Licensed CC0.

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