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U.S. Department of Health and Human Services

Enforcement Report - Week of December 26, 2013

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Event Detail

Event ID 66963
Product Type Devices
Status Ongoing
Recalling Firm Roche Diagnostics Operations, Inc.
City Indianapolis
State IN
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-11-25
Initial Firm Notification of
Consignee or Public
Distribution Pattern US Distribution including the states of AL, AZ, CA, CT, GA, NY, NC, NJ, OH, TX, VA and WA.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
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. 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, Class II 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 overview of the Pipetting Report (generated right after import of the xml file). If this issue has occurred, the corresponding Purification Report shows samples in a transposed order. However, the assigned sample information in the Purification Report (e.g., sample numbering, sample names, notes, position, and status) is correct; only the indicated sequence is wrong. This issue is not reproducible and only occurs randomly. To avoid a potential sample mismatch, discontinue use of the Pipetting Report to identify samples when manually pipetting samples after extraction. MagNA Pure processes that generate a sample list xml file for downstream applications are not affected as they do not use the Pipetting Report. The MagNA Pure 96 Instrument Operators Guide is being updated with an addendum addressing this issue. 27 Z-0536-2014