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This document informs customers about a labeling error in a specific lot of BCR-ABL Mbcr IS-MMR DX kits, detailing the necessary actions to address the error and the implications for usage of the

How to fill out field safety notice

How to fill out Field Safety Notice

1. Begin by identifying the product and its serial numbers.
2. Describe the nature of the safety issue or recall.
3. Provide clear instructions on what actions the recipient should take.
4. Include contact information for further inquiries.
5. Specify any deadlines for action, if applicable.
6. Ensure the notice is written in clear and easily understandable language.

Who needs Field Safety Notice?

1. Healthcare professionals using the product.
2. Hospitals and clinics that have distributed the product.
3. Patients who have received the product.
4. Regulatory bodies that monitor medical products.

People Also Ask about

What are the field safety corrective actions?

Here are a few other corrective action examples that specifically deals with workplace safety and business security: Providing equipment upgrades. Implementing safety training. Conducting regular and random safety audits.

What is a field safety notice?

Field Safety Notice. A communication sent out by a manufacturer or its representative to the device users in relation to a Field Safety Corrective Action.

What is an example of a safety corrective action?

Examples of corrective actions in food safety include discarding food that has been stored improperly, retraining staff on hygiene practices, and adjusting cooking or cooling methods to ensure safety standards are met.

What is a field safety notification?

A communication to customers and/or users sent out by a manufacturer or its representative in relation to a Field Safety Corrective Action.

What is a FSCA in MDR?

A Field Safety Corrective Action (FSCA) is defined in Article 2(68) of Regulation (EU) 2017/745 on medical devices (MDR) and Article 2(71) of Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) as a corrective action taken by the manufacturer for technical or medical reasons to prevent or reduce the

What is an example of a corrective action in ?

Corrective actions address an existing issue by identifying and eliminating its root cause to prevent recurrence. For example, if a machine breaks down due to poor maintenance, a corrective action would involve fixing the machine and improving the maintenance schedule.

What is an example of a field safety corrective action?

The FSCA may include; the return of a medical device to the supplier, device modification, device exchange, device destruction, retrofit by purchaser of manufacturer's modification or design change, advice given by manufacturer regarding the use of the device (e.g. where the device is no longer on the market or has

For pdfFiller’s FAQs

What is Field Safety Notice?

A Field Safety Notice (FSN) is a formal communication from a manufacturer to inform users about potential issues with a medical device that could affect health or safety.

Who is required to file Field Safety Notice?

Manufacturers of medical devices are typically required to file a Field Safety Notice when there is a risk associated with their products.

How to fill out Field Safety Notice?

To fill out a Field Safety Notice, manufacturers should provide information such as product details, the nature of the issue, affected batches, instructions for users, and contact information for further assistance.

What is the purpose of Field Safety Notice?

The purpose of a Field Safety Notice is to ensure that users and stakeholders are informed about potential risks, enabling them to take appropriate actions to mitigate any safety concerns.

What information must be reported on Field Safety Notice?

The information that must be reported on a Field Safety Notice includes product identifiers, description of the issue, risk assessment, corrective actions, and information on how users can report adverse events.