Device product
CDC, Influenza A/H5 Subtyping Kit, Model/Catalog Number: FluIVD03-11
Z-2220-2024
Product summary
- Event
- Event 94739
- Status
- Terminated
- Classification
- Class II
- Quantity
- 191 units
- Official record key
device-enforcement:Z-2220-2024
Official wording
Reason: The H5b component may fail to amplify, resulting in an inconclusive result.
Code information: Lot Code: Catalog # FluIVD03-11, lot 220307
Distribution pattern: US Nationwide distribution.
Derived failure modes
-
Unknown
The H5b component may fail to amplify, resulting in an inconclusive result.