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

FDA device recall Z-0536-2014 · posted 2013-12-18 · Terminated

Recall details

Recalling firm

Roche Diagnostics Operations, Inc.

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

Action taken

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.

Root cause

Software design

Status

Terminated

Product code

JJH

Quantity affected

27

Distribution

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

Date initiated

0013-11-25

Date posted

2013-12-18

Date terminated

2014-09-04

Location

Indianapolis, IN