Date Initiated by Firm April 26, 2024
Date Posted June 27, 2024
Recall Status1 Open3, Classified
Recall Number Z-2220-2024
Recall Event ID 94739
510(K)Number
K200370
Product Classification Influenza A and influenza B multiplex nucleic acid assay - Product Code OZE
Product CDC, Influenza A/H5 Subtyping Kit, Model/Catalog Number: FluIVD03-11

Code Information Lot Code: Catalog # FluIVD03-11, lot 220307
Recalling Firm/
Manufacturer Centers For Disease Control and Prevention
1600 Clifton Rd Ne
Atlanta GA 30329-4018

For Additional Information Contact Genomics and Diagnostics Team
404-639-3042
Manufacturer Reason
for Recall The H5b component may fail to amplify, resulting in an inconclusive result.
FDA Determined
Cause 2 Under Investigation by firm
Action 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.

Quantity in Commerce 191 units
Distribution US Nationwide distribution.