• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Enforcement Report - Week of December 26, 2013

  • Print
  • Share
  • E-mail
-

Product Detail

Product Description 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.
Recall Number Z-0536-2014
Classification Class II
Code Info 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,
Product Distributed Qty 27
Reason For Recall 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.

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 Letter
Distribution Pattern US Distribution including the states of AL, AZ, CA, CT, GA, NY, NC, NJ, OH, TX, VA and WA.
-
-