Roche Diagnostics Operations, Inc.: Medical Device Recall in 2013 - (Recall #: Z-0536-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: November 25, 2013

Date Posted: December 25, 2013

Recall Number: Z-0536-2014

Event ID: 66963

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

Status: Terminated

Product Quantity: 27

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,

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated