FDA Medical Device Recalls (openFDA)
Centers For Disease Control and Prevention: CDC, Influenza A/H5 Subtyping Kit, Model/Catalog Number: FluIVD03-11
- Recall number
- Z-2220-2024
- Recalling firm
- Centers For Disease Control and Prevention
- Product
- CDC, Influenza A/H5 Subtyping Kit, Model/Catalog Number: FluIVD03-11
- Status
- Terminated
- Initiated
- 2024-04-26
- Posted
- 2024-06-27
- Terminated
- 2025-02-05
- Reason
- The H5b component may fail to amplify, resulting in an inconclusive result.
- 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 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
- 191 units
- Distribution
- US Nationwide distribution.
- Lot, serial or model codes
- Lot Code: Catalog # FluIVD03-11, lot 220307
- 510(k) numbers
- ["K200370"]
- PMA numbers
- not on file
- Product code
- OZE
- Firm FEI
- 1050190
- Firm city
- Atlanta
- Firm state
- GA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28