Z-1432-2021 Class II Terminated
FDA device recall Z-1432-2021 was initiated by AZURE BIOTECH INC on March 2, 2021 and is designated Class II. Reason for recall: Due to Products being incorrect labeling "for diagnostic use" and labelled with an unsupported 24 month expiration dating. The recall status is terminated (terminated March 31, 2023). Affected quantity: Total 100,000 kits (FaStep and EcoTest Rapid Diagnostic Test kits).
Recall Details
- Product Type
- Devices
- Report Date
- April 28, 2021
- Initiation Date
- March 2, 2021
- Termination Date
- March 31, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- Total 100,000 kits (FaStep and EcoTest Rapid Diagnostic Test kits)
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.
Reason for Recall
Due to Products being incorrect labeling "for diagnostic use" and labelled with an unsupported 24 month expiration dating.
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.
Code Information
Lot Numbers: I2004001, I2004003, I2006128, I2005023, and I2006030