For In Vitro Diagnostic Use Only *** 25T 888 SARS-CoV-2 Antigen *** SARS-CoV-2 Antigen Rapid Qual...
FDA Device Recall #Z-1538-2021 — Class I — April 9, 2021
Recall Summary
| Recall Number | Z-1538-2021 |
| Classification | Class I — Serious risk |
| Date Initiated | April 9, 2021 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | INNOVA MEDICAL GROUP, INC. |
| Location | Pasadena, CA |
| Product Type | Devices |
| Quantity | 1,945 boxes (=48,625 individual tests) |
Product Description
For In Vitro Diagnostic Use Only *** 25T 888 SARS-CoV-2 Antigen *** SARS-CoV-2 Antigen Rapid Qualitative Test *** REF BT1309
Reason for Recall
Due to distributing test kits to customers who were not part of a clinical investigation.
Distribution Pattern
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.
Lot / 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
Other Recalls from INNOVA MEDICAL GROUP, INC.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1539-2021 | Class I | COVID-19 Self-Test Kit *** INNOVA *** 3T | Apr 9, 2021 |
| Z-1537-2021 | Class I | COVID-19 Self-Test Kit *** INNOVA *** 7T | Apr 9, 2021 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.