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Urgent Field Safety Notice Alar Ratio /INRatio2 PT/INR Monitoring System FSCAidentifier: IVD16.059 Type of action: Device Removal Date: 29 August 2016 Dear Valued Customer, The Alar Ratio/INRatio2
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How to fill out class 1 device recall
How to fill out class 1 device recall
01
Identify the reason for the recall of the class 1 device.
02
Notify the appropriate regulatory authority about the recall.
03
Prepare a recall strategy which includes communication plan, notification letter, and method of returning or disposing of the device.
04
Implement the recall by notifying customers, distributors, and other relevant parties.
05
Monitor and track the progress of the recall to ensure all affected devices are accounted for and addressed.
Who needs class 1 device recall?
01
Manufacturers of class 1 devices who have identified a safety or performance issue with their product.
02
Regulatory authorities who require the recall of class 1 devices due to potential risks to public health and safety.
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What is class 1 device recall?
Class 1 device recall is the most serious type of recall, where there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
Who is required to file class 1 device recall?
Manufacturers and distributors are required to file a class 1 device recall.
How to fill out class 1 device recall?
Class 1 device recall can be filled out by submitting a report to the appropriate regulatory agency, providing details on the reason for the recall, affected products, and proposed actions.
What is the purpose of class 1 device recall?
The purpose of class 1 device recall is to remove or correct products that pose a serious risk to public health.
What information must be reported on class 1 device recall?
Information such as the reason for the recall, affected product details, potential health risks, and proposed corrective actions must be reported on class 1 device recall.
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