CDC, Influenza A/H5 Subtyping Kit, Model/Catalog Number: FluIVD03-11
FDA device recall Z-2220-2024 · posted 2024-06-27 · Terminated
Recall details
- Recalling firm
- Centers For Disease Control and Prevention
- Reason for recall
- The H5b component may fail to amplify, resulting in an inconclusive result.
- Action taken
- 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.
- Root cause
- Under Investigation by firm
- Status
- Terminated
- Product code
- OZE
- Quantity affected
- 191 units
- Distribution
- US Nationwide distribution.
- Date initiated
- 2024-04-26
- Date posted
- 2024-06-27
- Date terminated
- 2025-02-05
- Location
- Atlanta, GA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| CDC 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 Kit (K200370) | Centers for Disease Control and Prevention | 2020-03-10 |