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Terminated

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.

FDA Recall Z-1432-2021 · Posted None

Recalling FirmAZURE BIOTECH INC
Recall StatusTerminated
Product CodeQKO
Date Initiated2021-03-02
Date Terminated2023-03-31
Product QuantityTotal 100,000 kits (FaStep and EcoTest Rapid Diagnostic Test kits)

Reason for Recall

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

Firm 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

Root Cause

Labeling False and Misleading

Distribution Pattern

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.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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