FDA recall Z-2220-2024
Centers For Disease Control and Prevention · Class II · device
Product
CDC, Influenza A/H5 Subtyping Kit, Model/Catalog Number: FluIVD03-11
Reason for recall
The H5b component may fail to amplify, resulting in an inconclusive result.
Distribution
US Nationwide distribution.
Key facts
- Status
- Terminated
- Initiation date
- 2024-04-26
- Report date
- 2024-07-03
- Termination date
- 2025-02-05
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Atlanta, GA, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2220-2024