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U.S. Department of Health and Human Services

Class 2 Device Recall CDC, Influenza A/H5 Subtyping Kit

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 Class 2 Device Recall CDC, Influenza A/H5 Subtyping Kitsee related information
Date Initiated by FirmApril 26, 2024
Date PostedJune 27, 2024
Recall Status1 Open3, Classified
Recall NumberZ-2220-2024
Recall Event ID 94739
510(K)NumberK200370 
Product Classification Influenza A and influenza B multiplex nucleic acid assay - Product Code OZE
ProductCDC, 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 ContactGenomics 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
ActionThe 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 Commerce191 units
DistributionUS Nationwide distribution.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = OZE
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