COVID-19 Self-Test Kit *** INNOVA *** 3T — Class I medical device recall Z-1539-2021
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-1539-2021 |
|---|---|
| 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 | U2102003, X2012310 |
Product
COVID-19 Self-Test Kit *** INNOVA *** 3T
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-1539-2021. 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.