Z-2452-2021 Class II Ongoing
FDA device recall Z-2452-2021 was initiated by Cellex on March 1, 2021 and is designated Class II. Reason for recall: The kit does not have an emergency use authorization (EUA). The recall status is ongoing. Affected quantity: Approximately 44,821 kits.
Recall Details
- Product Type
- Devices
- Report Date
- September 22, 2021
- Initiation Date
- March 1, 2021
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- Approximately 44,821 kits
Product Description
Cellex qSARS-Cov-2 Antigen Rapid Test, 25 tests/box, submitted as EUA202955 "declined to issue"
Reason for Recall
The kit does not have an emergency use authorization (EUA).
Distribution Pattern
US Nationwide distribution in the states of CA, FL, TX, and WI.
Code Information
All lot numbers