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

Class 2 Device Recall MagNA Pure 96 System

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards | Inspections
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 2 Recall
MagNA Pure 96 System
see related information
Date Posted December 18, 2013
Recall Status1 Open
Recall Number Z-0536-2014
Recall Event ID 66963
Product Classification Clinical Sample Concentrator - Product Code JJH
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.
Code Information 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,
Recalling Firm/
Manufacturer
Roche Diagnostics Operations, Inc.
9115 Hague Rd
Indianapolis, Indiana 46256-1025
For Additional Information Contact Todd Siesky
317-576-2000 Ext. 249
Manufacturer 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 overvi
FDA Determined
Cause 2
OTHER/UNDETERMINED: Under Investigation by the firm
Action Roche Diagnostics sent an URGENT Medical Device Correction Notice dated November 25, 2013, to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. Customers were advised to discontinue use of the Pipetting Report and to use the sample list file instead. The MagNA Pure 96 Instrument Operators Guide is being updated with an addendum addressing this issue. The letter included a Customer Response Form for customers to complete and return to the firm by FAX : 1-888-670-4135. Please contact the Roche Support Network Customer Support Center at 1-800-526-1247, 24 hours a day, seven days a week, if you have questions about the information contained in this UMDC.
Quantity in Commerce 27
Distribution US Distribution including the states of AL, AZ, CA, CT, GA, NY, NC, NJ, OH, TX, VA and WA.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
-
-