Abbott Molecular, Inc. is recalling 23 units of various in-vitro diagnostic kits and wash station assemblies that were intended for export only. These products were shipped to customers in the United States despite not being approved or registered according to U.S. specifications. Consumers should identify if they have any of the affected Vysis FISH probe kits or M1000 wash stations and contact the manufacturer for further instructions.
These products have not been approved or registered for use within the United States, meaning they may not meet the specific regulatory and safety standards required by the FDA for domestic clinical use.
Manufacturer Notification
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 · 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.