Recall Z-0536-2014— Roche Diagnostics Operations, Inc.

Class II FDA medical device recall by Roche Diagnostics Operations, Inc., initiated 2013-11-25, terminated 2014-09-04. FDA's recall record names no specific 510(k) clearance for this event. Product: 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.. Reason: 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.

Recalling firm

Roche Diagnostics Operations, Inc.

Classification

Class II

Status

Terminated

Initiated

2013-11-25

Terminated

2014-09-04

Firm location

Indianapolis, IN, United States

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