AZURE BIOTECH Assure COVID-19 IgG/IgM Rapid Test Device that include: 1) Pouch Label recall — FDA Z-1432-2021
Due to Products being incorrect labeling "for diagnostic use" and labelled with an unsupported 24 month expiration dating.
Overview of recall records associated with AZURE BIOTECH Inc., including dates, categories and classifications where available.
Classification mix: Class II: 1.
Due to Products being incorrect labeling "for diagnostic use" and labelled with an unsupported 24 month expiration dating.
This page summarizes recall records in which the official source identifies AZURE BIOTECH Inc. as the recalling firm or manufacturer. The number of records should not be treated as a safety rating or a measure of company size, because recall counts depend on product mix, reporting periods and how government records are organized.
Compare the dates, categories and classifications together rather than relying on the total alone. Open an individual record for the recalled product, reason, distribution details and current instructions available from the source.