For In Vitro Diagnostic Use Only *** 25T 888 SARS-CoV-2 Antigen ***… — Class I medical device recall Z-1538-2021
Ongoing recall by INNOVA MEDICAL GROUP, INC., reported 2021-06-16, distributed nationwide. Due to distributing test kits to customers who were not part of a clinical investigation.
| Recall number | Z-1538-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | INNOVA MEDICAL GROUP, INC., Pasadena, CA, United States |
| Recall initiated | 2021-04-09 |
| Classified | 2021-06-10 |
| Reported by FDA | 2021-06-16 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA, GB, IN |
| 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 |
| Model numbers | 25T, BT1309 |
Product
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1538-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.