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U.S. Department of Health and Human Services

Class 1 Device Recall INNOVA SARSCoV2 Antigen Rapid Qualitative Test

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  Class 1 Device Recall INNOVA SARSCoV2 Antigen Rapid Qualitative Test see related information
Date Initiated by Firm April 09, 2021
Create Date June 10, 2021
Recall Status1 Open3, Classified
Recall Number Z-1538-2021
Recall Event ID 87682
Product Classification Coronavirus antigen detection test system. - Product Code QKP
Product For In Vitro Diagnostic Use Only *** 25T 888 SARS-CoV-2 Antigen *** SARS-CoV-2 Antigen Rapid Qualitative Test *** REF BT1309
Code Information Catalog Number: 25T REF: Bt1309 Lot Numbers: U2101750 U2101751 X2006004 X2008001 X2008010 X2009002 X2009004 X2009013 X2009016 X2010004 X2010010 X2011005 X2011006 X2011007 X2011008 X2011009 X2011012 X2011013 X2011015 X2011016 X2011017 X2011025 X2011051 X2011052 X2012001 X2012002 X2012004 X2012005 X2012008 X2101002 X2101004 X2101014 X2101031 X2101038 
Recalling Firm/
800 E Colorado Blvd Ste 200
Pasadena CA 91101-5401
For Additional Information Contact Michael Malis
Manufacturer Reason
for Recall
Due to distributing test kits to customers who were not part of a clinical investigation.
FDA Determined
Cause 2
No Marketing Application
Action On or about 04/26/2021, the firm sent an "URGENT: MEDICAL DEVICE RECALL" Notification via email to its customers informing them that it is recalling products that were distributed outside of a clinical investigation and that the affected products are for investigational use only. The performance characteristics have not been establish and the tests should not be used to screen or diagnose COVID-19. The negative results obtained on the tests are not indicator of the status of SARS-CoV-2 infection. Customers are instructed to: -Check their inventory to see if they have in their possession the affected products. -If they have affected products, they are to count the test kits and write the number on the accompanying "MEDICAL DEVICE RECALL RETURN RESPONSE" form and return the form to the Recalling Firm via the provided FedEx envelope. -Destroy (by placing in your household waste) or return the affected products (Customer's choice), but to include the total number of destroyed and returned test on the "MEDICAL DEVICE RECALL RETURN RESPONSE" form. For any questions or assistance, contact Linda Weinreb at Linda.Weinreb@innovamedgroup.com or 747-494-0852.
Quantity in Commerce 1,945 boxes (=48,625 individual tests)
Distribution Worldwide distribution - U.S. Nationwide in the states of AL, AZ, CA, CO, CT, DC, DE, FL, GA, IL, IN, KY, MA, MD, ME, MI, MN, MO, NC, NE, NH, NJ, NV, NY, OH, PA, RI, TN, TX, UT, VA, VT, WA, and WI. The countries of Canada, India and United Kingdom.
Total Product Life Cycle TPLC Device Report

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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.