Houston, TX, United States
AZURE BIOTECH INC recalls
1 recall recorded since 2018, most recently on 2 March 2021. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)0
Terminated or completed1
Class I (FDA)0
Terminated Class II Medical devices
- Recall started
- 2 March 2021
- Terminated
- 31 March 2023
- Reason
- Due to Products being incorrect labeling "for diagnostic use" and labelled with an unsupported 24 month expiration dating.
- Distribution
- 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.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1432-2021
- 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
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.