Recall Z-2220-2024 ยท OZE Influenza A And Influenza B Multiplex Nucleic Acid Assay
Centers For Disease Control and Prevention
CDC, Influenza A/H5 Subtyping Kit, Model/Catalog Number: FluIVD03-11
| Date | Jun 27, 2024 (initiated Apr 26, 2024) |
| Status | Terminated |
| 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, procee |
| Quantity | 191 units |
| Distribution | US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K200370 | CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A/B Typing Kit, CDC Human Influenza Virus Real-ti Centers for Disease Control and Prevention, Mar 10, 2020 |