AZURE BIOTECH INC: Medical Device Recall in 2021 - (Recall #: Z-1432-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: March 2, 2021

Date Posted: April 28, 2021

Recall Number: Z-1432-2021

Event ID: 87541

Reason for Recall:

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

Status: Terminated

Product Quantity: Total 100,000 kits (FaStep and EcoTest Rapid Diagnostic Test kits)

Code Information:

Lot Numbers: I2004001, I2004003, I2006128, I2005023, and I2006030

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated