FDA-Device2021-04-28Class II

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 / Reli

AZURE BIOTECH INC

Hazard

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

Sold states

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.

Affected count

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

Manufactured in

5250 Gulfton St Ste 2c, N/A, Houston, TX, United States

Products

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.

Official notice

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

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