Module 19: Regulation of In Vitro Diagnostic Medical Devices

13/04/2023

Case Study #4

Device Pipette tips for use with a molecular biology analyser Event

Liquid dripping from pipette tips Potential clinical outcome?

Reportable? An event occurred

The device was a contributory cause The event could have led to harm

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Case Study #4

Device Pipette tips for use with a molecular biology analyser Event Liquid dripping from pipette tips

Action to be taken by user: Do not use affected batches. Review affected results

FSCA or FCA?

32

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