Reported Dec 25, 2013 · Terminated

MagNA Pure 96 System Version 1.0 Software Version 2.0 Robotic workstation for automated isolation of nucleic acids from…

Roche Diagnostics Operations, 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 Diagnostics Operations, Inc. · 9115 Hague Rd · Indianapolis, IN · 46256-1025

Is this the product you have?

  • MagNA Pure 96 System Version 1.0 Software Version 2.0 Robotic workstation for automated isolation of nucleic acids from different kinds of crude sample material (whole blood, serum, blood cells, culture cells, tissue, bacteria, fungi) by the use of the specially designed MagNA Pure reagent kits, automated filling of different kinds of PCR reaction vessels.
Lot codes and dates
    • Serial Numbers 2001
    • 2002
    • 2003
    • 2004
    • 2006
    • 2011
    • 2012
    • 2013
    • 2014
    • 2015
    • 2016
    • 2018
    • 2019
    • 2020
    • 2021
    • 2022
    • 2023
    • 2024
    • 2025
    • 2026
    • 2027
    • 2028
    • 4001
    • 4022
    • 4023
    • 4024
    • 4025
Amount recalled
27

Where it was sold

Why it was recalled

This issue is only relevant for customers importing xml files into the MagNA Pure 96 IVD instrument software for sample identification. There is a potential for sample mismatch when using the MagNA Pure 96 IVD instrument (catalog number 06541089001). Importing an order file in xml format to the MagNA Pure 96 IVD instrument software may result in a wrong sequence of samples in the graphical overvi

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 Sep 4, 2014 · Data as of Sep 19, 4:53 PM UTC

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