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IMPORTANT: URGENT FIELD SAFETY NOTICE Control Failures on the BIOFIRE FILMARRAY Pneumonia Panel and BIOFIRE FILMARRAY Pneumonia Panel plus Please distribute the attached customer letter. To the Laboratory
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Begin by gathering all necessary information about the FilmArray.
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04
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Healthcare professionals who use the FilmArray for diagnostic purposes.
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The evaluation of form FilmArray is a process to assess the performance and effectiveness of the FilmArray diagnostic systems which are used for the rapid detection of infectious diseases.
Individuals or organizations that utilize FilmArray diagnostic systems in clinical practice or laboratory settings are required to file this evaluation.
To fill out the evaluation of form FilmArray, users must provide relevant operational data, performance metrics, and any discrepancies observed during testing, ensuring to follow the standardized guidelines provided by the manufacturer.
The purpose of the evaluation is to ensure that FilmArray systems are functioning correctly, to validate their effectiveness, and to comply with regulatory requirements for diagnostic tools.
Information that must be reported includes system performance data, accuracy rates, any errors encountered, and compliance with regulatory standards.
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