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Class 2 Device Recall Fastep and Ecotest (authorized brand names for Assure COVID19 IgG/IgM Rapid Test Device) |
 |
| Date Initiated by Firm |
March 02, 2021 |
| Create Date |
April 16, 2021 |
| Recall Status1 |
Terminated 3 on March 31, 2023 |
| Recall Number |
Z-1432-2021 |
| Recall Event ID |
87541 |
| Product Classification |
Reagent, coronavirus serological - Product Code QKO
|
| 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. |
| Code Information |
Lot Numbers: I2004001, I2004003, I2006128, I2005023, and I2006030 |
Recalling Firm/
Manufacturer |
AZURE BIOTECH INC
5250 Gulfton St Ste 2c
Houston TX 77081-2936
|
| For Additional Information Contact |
Zoey Zhou
800-618-5829
|
Manufacturer Reason
for Recall |
Due to Products being incorrect labeling "for diagnostic use" and labelled with an unsupported 24 month expiration dating.
|
FDA Determined
Cause 2 |
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 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. |
| Total Product Life Cycle |
TPLC Device Report
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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