AZURE BIOTECH INC: 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.

Recall number

Z-1432-2021

Recalling firm

AZURE BIOTECH INC

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 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.

Status

Terminated

Initiated

2021-03-02

Posted

not on file

Terminated

2023-03-31

Reason

Due to Products being incorrect labeling "for diagnostic use" and labelled with an unsupported 24 month expiration dating.

Root cause

Labeling False and Misleading

Action

On 03/02/2021, the firm sent an "URGENT: Medical Device Recall" Notification Letter via email or mail to customers informing them that Rapid Test kits were incorrectly labeled as "for diagnostic use" and labeled with an unsupported expiration date. Between 03/22-26/2021, the firm sent a revised/follow-up Recall Notification Letter via email. Customers are instructed to: -Remove any stock from inventory and to not further distribute the affected products until the issue is resolved and to return any unused inventory to Recall Firm at 5250 Gulfton Street, Suite 2C, Houston TX 77081. In addition, customer are informed: 1) The Recalling Firm is advising that Healthcare providers administering these tests remind their patients that the test is not a diagnostic test. 2) The Recalling Firm will replace the recalled inventory and do not anticipate any product shortages. The Recalling Firm is also instructing to review the attached Rework Instructions for details on how to rework the product for distribution. 3) Complete acknowledge receipt of this recall notification by emailing recall@azure.bio or returning the attached letter to ATTN: Recall Dept, Azure Biotech Inc., 5250 Gulfton Street, Ste 2C, Houston TX 77081. For additional questions and assistance, contact the Recalling Firm's Director at recall@azure.bio, or Customer Service at 1-800-618-5829 Monday through Friday 9:00 a.m. to 5:00 p.m. CST

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.

Lot, serial or model codes

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

510(k) numbers

not on file

PMA numbers

not on file

Product code

QKO

Firm FEI

3014862351

Firm city

Houston

Firm state

TX

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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