Z-0536-2014Class II

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

Name: Z-0536-2014 MagNA Pure 96 System Version 1.0 Software Version 2.0 Robotic workstation for automated isolation of nucleic...
Creator: Roche Diagnostics Operations, Inc.
License: https://open.fda.gov/license/

Roche Diagnostics GmbH / Terminated / root cause: software

FDA source

Roche Diagnostics Operations, Inc. began a recall of 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.... FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0536-2014
Classification: Class II
Status: Terminated
Posted: 2013-12-18
Terminated: 2014-09-04
Recalling firm: Roche Diagnostics GmbH
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.
Product code: JJH Clinical Sample Concentrator
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
Root cause tag: software
FDA root cause: Software design
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.
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0536-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0536-2014	Class II	Terminated	Voluntary: Firm initiated	2013-12-25	2013-12-18

Product code JJH

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)