FDAClass IIDecember 19, 2012

The MagNA Pure 96 System recall: Software Issue

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…

Why was The MagNA Pure 96 System recalled?

Roche Molecular Systems, Inc. has become aware of a device-associated diagnostic software issue.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Device-associated diagnostic software

Product
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…
Recalling firm
Roche Molecular Systems, Inc.
Quantity
13 units
Distribution
Nationwide Distribution
Recall date
December 19, 2012
Classification
Class II
Status
Terminated
Agency
FDA (device)
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