Roche Molecular Systems, Inc. recalls MagNA Pure 24 System, GMMI: 07290519001 Product Usage:
Recalled Product
MagNA Pure 24 System, GMMI: 07290519001 Product Usage: The MagNA Pure 24 System is a fully automated clinical sample extractor. It extracts nucleic acids from various sample types, sample tubes, and volume inputs for multiple downstream applications. The main features of the system are : Scalable purification of 1 to 24 samples Primary/secondary tube handling Inventory and sample management via barcodes Efficient order management via host The MagNA Pure 24 System offers 4 run types: Purification (rack) run Purification (cartridge) run Post Elution run Sample transfer run
Hazard / Issue
Cross-contamination of samples has been reported when running the existing protocol on the system with the rack-based purification run.
Issued by
FDA
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