Recall Z-1538-2021— INNOVA MEDICAL GROUP, INC.
Class I · Ongoing
Class I FDA medical device recall by INNOVA MEDICAL GROUP, INC., initiated 2021-04-09. FDA's recall record names no specific 510(k) clearance for this event. Product: For In Vitro Diagnostic Use Only *** 25T 888 SARS-CoV-2 Antigen *** SARS-CoV-2 Antigen Rapid Qualitative Test *** REF BT1309. Reason: Due to distributing test kits to customers who were not part of a clinical investigation..
- Recalling firm
- INNOVA MEDICAL GROUP, INC.
- Classification
- Class I
- Status
- Ongoing
- Initiated
- 2021-04-09
- Firm location
- Pasadena, CA, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.