Recall Z-1956-2018— Roche Molecular Systems, Inc.
Class II · Terminated
Class II FDA medical device recall by Roche Molecular Systems, Inc., initiated 2018-05-02, terminated 2019-04-30. FDA's recall record names no specific 510(k) clearance for this event. 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. Reason: Cross-contamination of samples has been reported when running the existing protocol on the system with the rack-based purification run..
- Recalling firm
- Roche Molecular Systems, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2018-05-02
- Terminated
- 2019-04-30
- Firm location
- Branchburg, NJ, United States
Product description
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
Reason for recall
Cross-contamination of samples has been reported when running the existing protocol on the system with the rack-based purification run.
Data sourced from openFDA. This site is unofficial and independent of the FDA.