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.

Class I - Dangerous

🏥 Medical Devices Recalled: March 2, 2021 AZURE BIOTECH Diagnostic Equipment Nationwide

What Should You Do?

Check if you have this product:
Lot Numbers: I2004001, I2004003, I2006128, I2005023, and I2006030
Do not eat it: Even if it looks and smells fine, do not consume this product.
Throw it away or return it: You can return the product to the store for a full refund.
Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:: AZURE BIOTECH INC
Reason for Recall:: Due to Products being incorrect labeling "for diagnostic use" and labelled with an unsupported 24 month expiration dating.
Classification:: Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
Status:: terminated

Product Information

Full Description:

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.

Product Codes/Lot Numbers:

Lot Numbers: I2004001, I2004003, I2006128, I2005023, and I2006030

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1432-2021