Roche MagNA Pure 96 System Recalled for Potential Sample Mismatch
Roche Diagnostics is recalling 27 MagNA Pure 96 Systems due to a software issue that may cause sample mismatches when importing XML files.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a risk of sample mismatch in a medical diagnostic device, which fits the criteria for a High severity score (risk-of-harm products where injury has not yet been reported).
Plain-English summary
Roche Diagnostics Operations, Inc. is recalling 27 units of the MagNA Pure 96 System, Version 1.0, Software Version 2.0. This robotic workstation is used for the automated isolation of nucleic acids from various sample materials. The recall is limited to specific serial numbers distributed across 12 US states, including Alabama, Arizona, California, Connecticut, Georgia, New York, North Carolina, New Jersey, Ohio, Texas, Virginia, and Washington.
The recall is due to a software issue affecting customers who import XML files into the instrument for sample identification. Importing an order file in XML format may result in a wrong sequence of samples in the graphical overview, creating a potential for sample mismatch. This issue is only relevant to users utilizing this specific file import function.
Customers who have imported XML files into the MagNA Pure 96 IVD instrument software should contact Roche Diagnostics for further instructions on how to proceed. The affected units are identified by specific serial numbers listed in the recall documentation.
The recalled product
- 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 Mag
- Manufacturer
- Roche Diagnostics Operations, Inc.
- Affected units
- 27
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Serial Numbers 2001
- 2002
- 2003
- 2004
- 2006
- 2011
- 2012
- 2013
- 2014
- 2015
- 2016
- 2018
- 2019
- 2020
- 2021
- 2022
- 2023
- 2024
- 2025
- 2026
Distribution
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