Recall Z-1432-2021— AZURE BIOTECH INC

Class II FDA medical device recall by AZURE BIOTECH INC, initiated 2021-03-02, terminated 2023-03-31. FDA's recall record names no specific 510(k) clearance for this event. 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: Due to Products being incorrect labeling "for diagnostic use" and labelled with an unsupported 24 month expiration dating..

Recalling firm

AZURE BIOTECH INC

Classification

Class II

Status

Terminated

Initiated

2021-03-02

Terminated

2023-03-31

Firm location

Houston, TX, United States

Data sourced from openFDA. This site is unofficial and independent of the FDA.