Abbott Diagnostics Scarborough, Inc. is recalling approximately 1,109,832 ID NOW COVID-19 2.0, Influenza A/B 2, and RSV test kits. These kits are being recalled because they have a higher rate of invalid test results than what is specified in the product's instructions. While no injuries have been reported, an invalid result prevents the detection of respiratory viruses and requires patients to undergo repeat testing.
The affected test kits may fail to provide a result, leading to delays in diagnosing and treating COVID-19, influenza, or RSV. This defect forces healthcare providers to re-swab patients and run additional tests, which can delay clinical decision-making.
Simple point-of-care device to detect SARS-CoV-2 nucleic acid targets.
Multiplex nucleic acid assay for Influenza A and Influenza B.
Respiratory virus panel nucleic acid assay system for RSV detection.
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.
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.