MagNA Pure 96 System Version 1.0 Software Version 2.0 Robotic workstation for automated isol...
FDA Recall #Z-0536-2014 — Class II — November 25, 2013
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.
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
Recalling Firm
Roche Diagnostics Operations, Inc. — Indianapolis, IN
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
27
Distribution
US Distribution including the states of AL, AZ, CA, CT, GA, NY, NC, NJ, OH, TX, VA and WA.
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,
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated
What Should You Do?
Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.