CDC Influenza H5 Subtyping Kit may produce inconclusive test results
The CDC Influenza A/H5 Subtyping Kit's H5b component may fail to amplify, resulting in inconclusive results. 191 units were distributed nationwide.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is a FDA Class II diagnostic device recall due to potential amplification failure that may result in inconclusive test results. No illnesses or injuries have been reported, and the recall is precautionary to ensure diagnostic accuracy.
Plain-English summary
The CDC Influenza A/H5 Subtyping Kit (Model/Catalog Number: FluIVD03-11, Lot 220307) is a diagnostic test used to identify and confirm H5 influenza subtype in respiratory samples.
The H5b component of the kit may fail to amplify properly, which can result in inconclusive test results. An inconclusive result could require repeat testing to confirm or rule out H5 influenza infection.
The Centers for Disease Control and Prevention is recalling 191 units that were distributed nationwide. Healthcare providers and laboratories using this kit should discontinue testing with the affected lot and contact the CDC for replacement kits or guidance on alternative testing methods.
Patients who have been tested with the affected kit lot should consult with their healthcare provider if they have concerns about the reliability of their test result.
The recalled product
- Product
- CDC, Influenza A/H5 Subtyping Kit, Model/Catalog Number: FluIVD03-11
- Manufacturer
- Centers For Disease Control and Prevention
- Category
- Medical Device — Diagnostic Kit
- Affected units
- 191
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot Code: Catalog # FluIVD03-11
- lot 220307
Distribution
Distributed nationwide across the United States.
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