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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.

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Medium RiskFDA Device
Medical Devices/Diagnostic Equipment

ID NOW Influenza A & B 2 Kits Recalled for Increased Invalid Test Rates

Agency Publication Date: March 13, 2026
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Summary

Abbott Diagnostics Scarborough, Inc. is recalling approximately 111,984 units of ID NOW Influenza A & B 2 diagnostic test kits. The recall was initiated because certain test kits from a specific lot have shown a higher rate of "invalid" results compared to the standards set in the product instructions. If you have this product, stop using it and contact the manufacturer or your distributor to arrange for a return, replacement, or correction.

Risk

The affected lot has an increased frequency of invalid test results, which could delay patient diagnosis or require repeated testing, potentially impacting timely treatment for Influenza A or B.

What You Should Do

  1. Stop using the recalled ID NOW Influenza A & B 2 diagnostic test kits immediately.
  2. Check your inventory for List Number 427-000, Lot Number 000X133126, with an Expiration Date of 2027-02-21.
  3. Contact Abbott Diagnostics Scarborough, Inc. or your authorized distributor to arrange for the return, replacement, or correction of the impacted kits.
  4. Call the FDA: 1-888-463-6332 (1-888-INFO-FDA) for additional questions regarding medical device recalls.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled product. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: ID NOW Influenza A & B 2
Model / REF:
427-000
Lot Numbers:
000X133126 (Exp 2027-02-21)
UDI:
10811877010422

Product Description: Influenza A/B virus nucleic acid IVD, kit, nucleic acid technique

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 98400
Status: Active
Manufacturer: Abbott Diagnostics Scarborough, Inc.
Sold By: authorized distributors
Manufactured In: United States
Units Affected: 111984 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.