Go Backs
HomeCategoriesStatesCheck Your Home
Go Backs

Track product recalls and safety alerts from CPSC, FDA, NHTSA, and USDA. Stay informed and keep your family safe.

Browse

  • Categories
  • States
  • Check Your Home
  • Risk Levels

Agencies

  • CPSC
  • FDA Food
  • FDA Drug
  • FDA Device
  • FDA Veterinary
  • NHTSA
  • USDA

Company

  • About
  • FAQ
  • Contact
  • Terms of Service
  • Privacy Policy
Buy Me a Coffee

Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

ยฉ 2026 Go Backs. All rights reserved.

Medium RiskFDA Device
Medical Devices/Diagnostic Equipment

Centers For Disease Control and Prevention: Influenza A/H5 Subtyping Kit Recalled for Potential Inconclusive Results

Agency Publication Date: June 27, 2024
Share:
Sign in to monitor this recall

Summary

The Centers for Disease Control and Prevention has recalled 191 units of the CDC Influenza A/H5 Subtyping Kit (Model/Catalog Number FluIVD03-11). The recall was initiated because the H5b component of the kit may fail to amplify correctly during testing. This failure can lead to an inconclusive test result, which could delay the accurate identification of influenza strains in clinical samples.

Risk

If the test kit fails to amplify the H5b component, it produces an inconclusive result rather than a clear positive or negative. This could lead to a delay in diagnosis and appropriate public health response or medical treatment for patients.

What You Should Do

  1. Immediately check your laboratory inventory for the CDC Influenza A/H5 Subtyping Kit with Catalog Number FluIVD03-11 and Lot Number 220307.
  2. Discontinue use of any test kits from the affected lot (220307) immediately.
  3. Contact your healthcare provider or the Centers for Disease Control and Prevention directly for further instructions regarding the disposal or return of the affected test kits and information on obtaining replacement units.
  4. Contact the FDA at 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices/medical-device-recalls for additional information or to report any issues.

Your Remedy Options

๐Ÿ“‹Other Action

Contact manufacturer for instructions

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: CDC, Influenza A/H5 Subtyping Kit
Model / REF:
FluIVD03-11
Lot Numbers:
220307

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 94739
Status: Resolved
Manufacturer: Centers For Disease Control and Prevention
Manufactured In: United States
Units Affected: 191 units
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.