FDA Device recall Z-2220-2024
CDC, Influenza A/H5 Subtyping Kit, Model/Catalog Number: FluIVD03-11
- FDA Device
- Class II
- terminated
- Published 2024-07-03
On 2024-07-03 the FDA classified a Class II recall of CDC, Influenza A/H5 Subtyping Kit, Model/Catalog Number: FluIVD03-11 by Centers For Disease Control And Prevention, citing the H5b component may fail to amplify, resulting in an inconclusive result.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2220-2024 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2024-04-26 |
| Published | 2024-07-03 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Centers For Disease Control And Prevention |
| Distribution | US |
Product
CDC, Influenza A/H5 Subtyping Kit, Model/Catalog Number: FluIVD03-11
Reason
The H5b component may fail to amplify, resulting in an inconclusive result.
Identifiers
| code_info | Lot Code: Catalog # FluIVD03-11, lot 220307 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2220-2024%22
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