FDA Device recall Z-1537-2021
COVID-19 Self-Test Kit *** INNOVA *** 7T
- FDA Device
- Class I
- ongoing
- Published 2021-06-16
On 2021-06-16 the FDA classified a Class I recall of COVID-19 Self-Test Kit *** INNOVA *** 7T by Innova Medical Group, citing due to distributing test kits to customers who were not part of a clinical investigation.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1537-2021 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2021-04-09 |
| Published | 2021-06-16 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Innova Medical Group |
| Distribution | US |
Product
COVID-19 Self-Test Kit *** INNOVA *** 7T
Reason
Due to distributing test kits to customers who were not part of a clinical investigation.
Identifiers
| code_info | Catalog Number: 7T Lot Numbers: U2101748 U2102001 U2102002 X2012711 X2103792 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1537-2021%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.