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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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Apr 30, 2019 · Data as of Sep 19, 5:29 PM UTC

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