Z-0421-2022 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- January 5, 2022
- Initiation Date
- November 4, 2021
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 200,100 units
Product Description
FLOWFLEX SARS-COV-2 Antigen Rapid Test (Self-Testing), 1 Test
Reason for Recall
Devices are determined to be inconsistent with the firm's Emergency Use Authorization (EUA). This product has not been authorized for emergency use and the test cannot be determined to be adequately validated for the stated intended use.
Distribution Pattern
NY
Code Information
UDI #: 6921756492427 Lot codes: COV1080232 - Expiration date: 05/13/2023; COV1095004 - Expiration date: 09/03/2023