Device product
Nasopharyngeal sample collection tray for COVID-19 testing, labeled as COVID TEST KIT NONSTERILE 184312, AHCV18A
Z-1277-2022
Product summary
- Event
- Event 90324
- Status
- Ongoing
- Classification
- Class I
- Quantity
- 274,400 kits total
- Official record key
device-enforcement:Z-1277-2022
Official wording
Reason: Affected products were assembled off-site by individuals who may not have been properly trained.
Code information: UDI-DI: 00191072121233 Lots: 721211, 672211, 657211, 994221, 980221, 974221
Distribution pattern: US distribution in the state of Minnesota.
Derived failure modes
-
Unknown
Affected products were assembled off-site by individuals who may not have been properly trained.