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Recall Observatory FDA recall evidence

Device 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.

Z-0536-2014

November 25, 2013

Class II

Product summary

Firm
Roche Diagnostics Operations, Inc.
Event
Event 66963
Status
Terminated
Classification
Class II
Quantity
27
Official record key
device-enforcement:Z-0536-2014

Official wording

Reason: 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

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.

Derived failure modes

  • Device software or design

    reason.device_software_design · v1.0.0

    software may result in