Company: Roche Molecular Systems, Inc.
Date of Enforcement Report 12/19/12
Class ll:

PRODUCT

Roche Applied Science MagNA Pure LC Version 3.0. The MagNA Pure LC (version 3.0) is a sample preparation instrument that can be used with the LightCycler instrument for automated isolation of nucleic acids in various types of biological materials. Recall Number Z-0485-2013

REASON
Symantec, a third party software vendor, informed Roche about a defect in their pcAnywhere software (versions 12.6.6 and older), which is a software product for accessing PCs remotely. The defect is a “pre authentication vulnerability” which allows hackers to gain full access to the target system without having to log on. The following Roche products are potentially affected by this issue: AMPLILINK Data Station, MagNA Pure LC, MagNA Pure 96 Instrument IVD, LightCycler 1.2 Instrument, LightCycler 2.0 Instrument, cobas 8000, Instrument Manager, DataCare GM, DataCare POC and COBAS INTEGRA 400/400+ .

RECALLING FIRM/MANUFACTURER
Roche Molecular Systems, Inc. Branchburg, NJ on 6/25/2012. Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
816 units

DISTRIBUTION
Nationwide

___________________________________