CDC — Class II medical device recall Z-2220-2024
Terminated recall by Centers For Disease Control and Prevention, reported 2024-07-03, distributed nationwide. The H5b component may fail to amplify, resulting in an inconclusive result.
| Recall number | Z-2220-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Centers For Disease Control and Prevention, Atlanta, GA, United States |
| Recall initiated | 2024-04-26 |
| Classified | 2024-06-27 |
| Reported by FDA | 2024-07-03 |
| Terminated | 2025-02-05 |
| Distributed | Nationwide (US) |
| Quantity | 191 units |
| Reason classes | device malfunction |
| Lot numbers | 220307 |
| Model numbers | FLUIVD03-11 |
Product
CDC, Influenza A/H5 Subtyping Kit, Model/Catalog Number: FluIVD03-11
Reason for recall
The H5b component may fail to amplify, resulting in an inconclusive result.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2220-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.