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962324AE
October 2011IMMAGE Immunochemistry Systems
Maintenance Logbook
This manual is intended for use with
IMAGE Immunochemistry System
IMAGE 800 Immunochemistry System
Introduction Beckman Coulter
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How to fill out class 2 device recall

How to fill out class 2 device recall
01
Obtain the necessary recall forms and documents from the appropriate regulatory agency.
02
Fill out the forms with accurate and detailed information about the device being recalled.
03
Clearly state the reason for the recall and provide any supporting evidence or data.
04
Include contact information in case any questions or concerns arise during the recall process.
05
Submit the completed forms to the regulatory agency and await further instructions on how to proceed.
Who needs class 2 device recall?
01
Manufacturers of class 2 medical devices who have identified issues with their products that pose a moderate risk to patient health or safety.
02
Healthcare facilities and providers who have received or used class 2 medical devices that have been recalled.
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What is class 2 device recall?
Class 2 device recall is initiated when a medical device is found to have a moderate risk of causing harm to patients.
Who is required to file class 2 device recall?
Manufacturers, distributors, and importers of medical devices are required to file for a class 2 device recall.
How to fill out class 2 device recall?
Class 2 device recall can be filled out by submitting a recall strategy plan to the appropriate regulatory authority.
What is the purpose of class 2 device recall?
The purpose of class 2 device recall is to remove or correct devices that pose a moderate risk to patient safety.
What information must be reported on class 2 device recall?
Information required for class 2 device recall includes device identification, reason for recall, health hazard evaluation, and action plan.
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