CDC, Influenza A/H5 Subtyping Kit, Model/Catalog Number: FluIVD03-11
FDA Recall #Z-2220-2024 — Class II — April 26, 2024
Product Description
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.
Recalling Firm
Centers For Disease Control and Prevention — Atlanta, GA
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
191 units
Distribution
US Nationwide distribution.
Code Information
Lot Code: Catalog # FluIVD03-11, lot 220307
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated