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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

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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Class 2 device recall is initiated when a medical device is found to have a moderate risk of causing harm to patients.
Manufacturers, distributors, and importers of medical devices are required to file for a class 2 device recall.
Class 2 device recall can be filled out by submitting a recall strategy plan to the appropriate regulatory authority.
The purpose of class 2 device recall is to remove or correct devices that pose a moderate risk to patient safety.
Information required for class 2 device recall includes device identification, reason for recall, health hazard evaluation, and action plan.
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