Z-2220-2024Class II

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

Name: Z-2220-2024 CDC, Influenza A/H5 Subtyping Kit, Model/Catalog Number: FluIVD03-11
Creator: Centers For Disease Control and Prevention
Published: 2024-04-26
License: https://open.fda.gov/license/

Centers for Disease Control and Prevention / initiated 2024-04-26 / Terminated

FDA source

Centers For Disease Control and Prevention began a recall of CDC, Influenza A/H5 Subtyping Kit, Model/Catalog Number: FluIVD03-11 on 2024-04-26. FDA classified it as Class II and gives the reason as "The H5b component may fail to amplify, resulting in an inconclusive result". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2220-2024
Classification: Class II
Status: Terminated
Initiated: 2024-04-26
Posted: 2024-06-27
Terminated: 2025-02-05
Recalling firm: Centers for Disease Control and Prevention
Product: CDC, Influenza A/H5 Subtyping Kit, Model/Catalog Number: FluIVD03-11
Product code: OZE Influenza A And Influenza B Multiplex Nucleic Acid Assay
Reason for recall: The H5b component may fail to amplify, resulting in an inconclusive result.
FDA root cause: 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 [email protected] 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 [email protected] with any inconclusive results.
Quantity in commerce: 191 units
Distribution: US Nationwide distribution.
Product codes and lots: Lot Code: Catalog # FluIVD03-11, lot 220307

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2220-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2220-2024	Class II	Terminated	Voluntary: Firm initiated	2024-07-03	2024-06-27

Product code OZE

K200370Class IICDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A/B Typing Kit, CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A Subtyping Kit, CDC Human Influenza Virus Real-time RT-PCR, Influenza A/H5 Subtyping KitCenters for Disease Control and Prevention / cleared 2020-03-10

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)