FDA Enforcement
Class II
Terminated
CDC, Influenza A/H5 Subtyping Kit, Model/Catalog Number: FluIVD03-11
Recall: Z-2220-2024
·
Reported July 3, 2024
Enforcement
- Recall Number
- Z-2220-2024
- Event ID
- 94739
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Centers For Disease Control and Prevention
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- July 3, 2024
- Initiation Date
- April 26, 2024
- Classification Date
- June 27, 2024
- Termination Date
- February 5, 2025
- Address
- 1600 Clifton Rd Ne, Atlanta, GA, 30329-4018, United States
Description
CDC, Influenza A/H5 Subtyping Kit, Model/Catalog Number: FluIVD03-11
Reason
The H5b component may fail to amplify, resulting in an inconclusive result.
Code Info
Lot Code: Catalog # FluIVD03-11, lot 220307
Distribution
US Nationwide distribution.
Quantity
191 units