Z-1277-2022 Class I Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- July 13, 2022
- Initiation Date
- May 2, 2022
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 274,400 kits total
Product Description
Nasopharyngeal sample collection tray for COVID-19 testing, labeled as COVID TEST KIT NONSTERILE 184312, AHCV18A
Reason for Recall
Affected products were assembled off-site by individuals who may not have been properly trained.
Distribution Pattern
US distribution in the state of Minnesota.
Code Information
UDI-DI: 00191072121233 Lots: 721211, 672211, 657211, 994221, 980221, 974221