Assure COVID-19 IgG/IgM Rapid Test Device that include recall: Labeling Error
Assure COVID-19 IgG/IgM Rapid Test Device that include: 1) Pouch Label - FaStep Rapid Diagnostic Test *** Rapid Reliable Simple *** COVID-19 IgG/IgM…
Why was Assure COVID-19 IgG/IgM Rapid Test Device that include recalled?
Due to Products being incorrect labeling "for diagnostic use" and labelled with an unsupported 24 month expiration dating.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot Numbers: I2004001, I2004003, I2006128, I2005023, and I2006030
- 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…
- Recalling firm
- AZURE BIOTECH INC
- Quantity
- Total 100,000 kits (FaStep and EcoTest Rapid Diagnostic Test kits)
- 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.
- Recall date
- April 28, 2021
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)