Device Recall MagNA Pure 96 System

Model / Serial
Device-associated diagnostic software
Product Classification
General Hospital and Personal Use Devices
Device Class
Unclassified
Implanted device?
No
Distribution
Nationwide Distribution
Product Description
The MagNA Pure 96 System (versions 1.0 and 2.0) is a sample preparation instrument for automated isolation of nucleic acids in various types of biological materials. This is a general purpose instrument. There are no corresponding assays.
Manufacturer
Roche Molecular Systems, Inc.
1 Event
- Recall of Device Recall MagNA Pure 96 System

Manufacturer

Roche Molecular Systems, Inc.

Manufacturer Address
Roche Molecular Systems, Inc., 1080 Us Highway 202 S, Branchburg NJ 08876-3733
Manufacturer Parent Company (2017)
Roche Holding AG
Source
USFDA

One device with a similar name

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Device Recall MagNA Pure 96 System

Model / Serial
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.
Product Classification
Clinical Chemistry and Clinical Toxicology Devices
Device Class
1
Implanted device?
No
Distribution
US Distribution including the states of AL, AZ, CA, CT, GA, NY, NC, NJ, OH, TX, VA and WA.
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.
Manufacturer
Roche Diagnostics Operations, Inc.

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Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

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