Z-1432-2021Class II

Assure COVID-19 IgG/IgM Rapid Test Device that include: 1) Pouch Label - FaStep Rapid Diagnostic Test ***...

Name: Z-1432-2021 Assure COVID-19 IgG/IgM Rapid Test Device that include: 1) Pouch Label - FaStep Rapid Diagnostic Test ***...
Creator: Azure Biotech Inc
Published: 2021-03-02
License: https://open.fda.gov/license/

Azure Biotech Inc / initiated 2021-03-02 / Terminated / root cause: labeling and UDI

FDA source

AZURE BIOTECH INC began a recall of 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... on 2021-03-02. FDA classified it as Class II and gives the reason as "Due to Products being incorrect labeling "for diagnostic use" and labelled with an unsupported 24 month expiration dating". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1432-2021
Classification: Class II
Status: Terminated
Initiated: 2021-03-02
Posted: 2021-04-16
Terminated: 2023-03-31
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.
Product code: QKO Reagent, Coronavirus Serological
Reason for recall: Due to Products being incorrect labeling "for diagnostic use" and labelled with an unsupported 24 month expiration dating.
Root cause tag: labeling and UDI
FDA 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 [email protected] 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 [email protected], or Customer Service at 1-800-618-5829 Monday through Friday 9:00 a.m. to 5:00 p.m. CST
Quantity in commerce: 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.
Product codes and lots: Lot Numbers: I2004001, I2004003, I2006128, I2005023, and I2006030

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1432-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1432-2021	Class II	Terminated	Voluntary: Firm initiated	2021-04-28	2021-04-16

Product code QKO

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)