CDC H5 Influenza Subtyping Kit – Amplification Failure (2024)
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
CDC, Influenza A/H5 Subtyping Kit, Model/Catalog Number: FluIVD03-11
Brand
Centers For Disease Control and Prevention
Lot Codes / Batch Numbers
Lot Code: Catalog # FluIVD03-11, lot 220307
Products Sold
Lot Code: Catalog # FluIVD03-11, lot 220307
Centers For Disease Control and Prevention is recalling CDC, Influenza A/H5 Subtyping Kit, Model/Catalog Number: FluIVD03-11 due to The H5b component may fail to amplify, resulting in an inconclusive result.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
The H5b component may fail to amplify, resulting in an inconclusive result.
Recommended Action
Per FDA guidance
The CDC notified customers via letter on 04/26/2024. Customers were instructed to halt use of the H5b component when testing a specimen with the CDC Influenza A/H5 subtyping kit, lot 220307. Proceed with testing with the InfA, H5a, and RP targets and do not delay resulting. If a specimen is positive for InfA and H5a, that is considered a presumptive H5 positive and should be sent to CDC immediately. Please reach out to flusupport@cdc.gov for further shipping guidance. If a specimen is positive for InfA and negative for H5a and has not been tested with the Influenza A Subtyping kit, proceed to testing the specimen with the Influenza A Subtyping kit. If a specimen is negative for all viral targets but positive for RP, that specimen is considered negative for Influenza A, H5. Please reach out to flusupport@cdc.gov with any inconclusive results.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026