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ABL800 analyzers; Low McCrea results patient samplesDear Customer
Radiometer has recently become aware that the ABL800
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What is urgent field safety notice?
Urgent field safety notice is a notification regarding a potential safety issue with a product that requires immediate action to prevent harm.
Who is required to file urgent field safety notice?
Manufacturers, distributors, and importers of medical devices are required to file urgent field safety notices.
How to fill out urgent field safety notice?
Urgent field safety notices can be filled out online through regulatory authorities' websites, providing details about the safety issue and actions needed.
What is the purpose of urgent field safety notice?
The purpose of urgent field safety notice is to inform relevant parties about potential safety hazards associated with a product and to prompt appropriate corrective actions.
What information must be reported on urgent field safety notice?
Information such as product details, nature of safety issue, affected lot numbers, distribution information, and recommended actions must be reported on an urgent field safety notice.
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