Medical device recalls Moderate risk

Centers For Disease Control and Prevention recalls CDC, Influenza A/H5 Subtyping Kit, Model/Catalog Number: FluIVD03-11

Recall date
April 26, 2024
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-2220-2024
FDA classification
Class II
Brand / firm
Centers For Disease Control and Prevention
Sold / distributed
US Nationwide distribution.

Why it was recalled

The H5b component may fail to amplify, resulting in an inconclusive result.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

CDC, Influenza A/H5 Subtyping Kit, Model/Catalog Number: FluIVD03-11

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