FDA 483 - Luminex Corporation - January 20, 2023

An FDA inspection of Luminex Corporation in Northbrook, IL, revealed that the firm had not adequately implemented its written Medical Device Reporting (MDR) procedures. This led to multiple instances of delayed and incomplete reporting of adverse events and device malfunctions for their VERIGENE EP and BC-GN IVD medical devices. The findings indicate a significant failure in regulatory compliance regarding post-market surveillance.