Get the free Field Safety Notice for PO1162A Brilliance - mhra gov
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This document informs about the recall of PO1162A Brilliance MRSA Agar, lot number 1085844, and outlines the necessary actions required by recipients.
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How to fill out Field Safety Notice for PO1162A Brilliance
01
Start by entering the date of the notice at the top of the form.
02
Fill in the details of the product related to PO1162A Brilliance, including the model number and batch/serial number.
03
Describe the reason for the Field Safety Notice, including potential risks and safety concerns.
04
Include instructions on what actions recipients should take, such as ceasing use or returning the product.
05
Provide contact details for further assistance, including phone numbers and email addresses.
06
Review the completed notice for accuracy before distribution.
Who needs Field Safety Notice for PO1162A Brilliance?
01
Healthcare professionals and facilities using the PO1162A Brilliance product.
02
Patients who have received treatment or diagnosis related to the PO1162A Brilliance.
03
Regulatory bodies and health authorities overseeing product safety.
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What is Field Safety Notice for PO1162A Brilliance?
The Field Safety Notice for PO1162A Brilliance is a communication issued to inform stakeholders about potential safety issues related to the product, outlining recommended actions to mitigate risks.
Who is required to file Field Safety Notice for PO1162A Brilliance?
Healthcare providers, distributors, and manufacturers involved with the PO1162A Brilliance are required to file the Field Safety Notice.
How to fill out Field Safety Notice for PO1162A Brilliance?
To fill out the Field Safety Notice for PO1162A Brilliance, include the product details, the nature of the safety issue, recommended actions, timelines for reporting back, and contact information for further inquiries.
What is the purpose of Field Safety Notice for PO1162A Brilliance?
The purpose of the Field Safety Notice for PO1162A Brilliance is to ensure that all parties are informed of the safety issue and to provide clear guidance on corrective actions to protect patient safety.
What information must be reported on Field Safety Notice for PO1162A Brilliance?
The information that must be reported includes product identification, description of the safety issue, risk assessment, corrective actions to be taken, and contact information for the reporting authority.
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