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This document serves as an urgent safety notice regarding the presence of CD10 in certain BD™ CD7 reagents and provides instructions on how to handle the affected products.
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How to fill out urgent field safety notice
How to fill out URGENT FIELD SAFETY NOTICE
01
Start by reading the URGENT FIELD SAFETY NOTICE thoroughly to understand its purpose and importance.
02
Identify the specific product or device involved in the notice.
03
Fill out the date of completion in the designated field.
04
Provide the contact information of the person responsible for managing the notice in your organization.
05
Indicate the reason for the urgency, according to the details provided in the notice.
06
List the actions that need to be taken by the recipients of the notice.
07
Include a section for the recipients to confirm receipt of the notice by signing and dating.
08
Make sure to review the completed notice for accuracy before distribution.
Who needs URGENT FIELD SAFETY NOTICE?
01
Healthcare professionals who use the affected product or device.
02
Hospitals and clinics that have distributed the product to their facilities.
03
Patients who may be impacted by the safety notice.
04
Regulatory authorities that require notification regarding product safety issues.
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People Also Ask about
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
What is the functional safety standard for medical devices?
Generally, functional safety deals with hazards, which arise from the function of a device. ing to IEC 61508 it is the ability of a safety-related system to carry out the actions necessary to achieve a safe state for the EUC (equipment under control) or to maintain a safe state for the EUC.
What is a FSCA in medical devices?
A field safety corrective action (FSCA) is an action taken by a manufacturer to reduce a risk of death or serious deterioration in the state of health associated with the use of an IVD that is already placed on the market.
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 a benefit risk assessment for medical devices?
It entails evaluating the device's possible benefits as well as drawbacks and deciding if the advantages outweigh the disadvantages. This examination aids in ensuring that medical devices are reliable, safe, and capable of being used by patients without harm.
What is the full form of FSCA?
The Financial Sector Conduct Authority (FSCA) is responsible for market conduct regulation and supervision.
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 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
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What is URGENT FIELD SAFETY NOTICE?
An URGENT FIELD SAFETY NOTICE is a communication issued to inform healthcare professionals and facilities about safety issues related to medical devices or products that may pose a risk to patients.
Who is required to file URGENT FIELD SAFETY NOTICE?
Manufacturers of medical devices and products are required to file an URGENT FIELD SAFETY NOTICE when there are safety concerns that could affect the performance or safety of their products.
How to fill out URGENT FIELD SAFETY NOTICE?
Filling out an URGENT FIELD SAFETY NOTICE involves providing details about the product, nature of the safety issue, instructions for users, and any corrective actions that need to be taken.
What is the purpose of URGENT FIELD SAFETY NOTICE?
The purpose of an URGENT FIELD SAFETY NOTICE is to ensure the safety of patients and users by promptly informing them of any potential risks associated with a medical product and recommending necessary actions.
What information must be reported on URGENT FIELD SAFETY NOTICE?
The URGENT FIELD SAFETY NOTICE must report information including the product identification, description of the issue, potential risks, risk mitigation measures, and contact information for further inquiries.
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