Device product
Oral Rapid SARS-CoV-2 Antigen Rapid Test Kit; COVID 19 Test
Z-1044-2022
Product summary
- Event
- Event 89995
- Status
- Ongoing
- Classification
- Class I
- Quantity
- 34,240 units
- Official record key
device-enforcement:Z-1044-2022
Official wording
Reason: Firm distributed tests which have not been cleared or authorized for marketing or distribution in the United States.
Code information: All lots
Distribution pattern: US distributions to states of: AL and GA.
Derived failure modes
-
Unknown
Firm distributed tests which have not been cleared or authorized for marketing or distribution in the United States.