Azure Biotech Recalls Assure COVID-19 Rapid Test Devices for Labeling Errors
Azure Biotech Inc. is recalling 100,000 Assure COVID-19 IgG/IgM Rapid Test Devices due to incorrect diagnostic labeling and unsupported expiration dating.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II and involves minor labeling errors regarding diagnostic use and expiration dating, which aligns with the rubric for moderate severity.
Plain-English summary
Azure Biotech Inc. is recalling 100,000 units of the Assure COVID-19 IgG/IgM Rapid Test Device, which includes FaStep and EcoTest brand kits. The recall is due to incorrect labeling that states "for diagnostic use" and the use of an unsupported 24-month expiration date.
The affected products were distributed worldwide, including nationwide in the United States in the states of California, Florida, Georgia, Illinois, Louisiana, Maryland, Minnesota, North Carolina, Texas, Utah, Virginia, and Washington, as well as in Canada. The specific lot numbers involved are I2004001, I2004003, I2006128, I2005023, and I2006030.
Consumers and healthcare providers should stop using these test kits and contact Azure Biotech Inc. for further instructions or a refund. The recall is classified as Class II by the FDA, indicating a reasonable probability that use of the product could cause temporary or medically reversible health consequences.
The recalled product
- 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…
- Manufacturer
- AZURE BIOTECH INC
- Hazard
- Affected units
- 100,000
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (5)
- Lot Numbers: I2004001
- I2004003
- I2006128
- I2005023
- and I2006030
Distribution
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