Reported Jun 6, 2018 · Terminated
MagNA Pure 24 System, GMMI: 07290519001 Product Usage: The MagNA Pure 24 System is a fully automated clinical sample…
Roche Molecular Systems, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Roche Molecular Systems, Inc. · 1080 US Highway 202 S · Branchburg, NJ · 08876-3733
Is this the product you have?
- MagNA Pure 24 System
- GMMI07290519001
- Product UsageThe 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 areScalable 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 typesPurification (rack) run Purification (cartridge) run Post Elution run Sample transfer run
- Lot codes and dates
- Device Identifier07613336106174
- Amount recalled
- 163 units
Where it was sold
Why it was recalled
Cross-contamination of samples has been reported when running the existing protocol on the system with the rack-based purification run.
This product could cause temporary or reversible health problems — stop using it.
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